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PRODUCT DESCRIPTION
BD 328438 - Insulin Syringe 3/10ml 31Gx5/16" 100/BX, 5 BX/CS
328438 - BD Insulin Syringes with the BD Ultra-Fine needle 8mm x 31G 3/10 mL/cc
BD 328468 Ultra-Fine Needle is a 31-gauge, 8mm (3/10") syringe needle engineered to provide comfort, accuracy and ease in injecting. Reduces the risk of a painful injection in the muscle.
Why shorter is more comfortable?
Most people prefer short needles. They are more comfortable and less threatening, so its easier to start injecting insulin. Short needles also help prevent injections from going into muscle, which can result in pain and poor blood sugar control.
Needle length (mm)
Insulin needles come in different lengths. BD Original Needles are 12.7 mm (1/2") long, and BD Short Needles are 8 mm (5/16") long. The BD Nano Needle 4mm (3/16") and BD Mini Needle 5mm (5/32") are available only in pen needles. For a comfortable injection experience, shorter needle lengths are recommended and preferred.
Needle gauge (G)
The higher the gauge, the thinner the needle. For example, 32G is thinner than a 31G needle.Insulin needles are available in many gauges (G), or thicknesses. The higher the gauge, the thinner the needle. For example, a 32 G needle is actually thinner and more comfortable than a 29 G needle.
Thin Wall
Thin Wall: As shown in the diagram, the thin wall needle has a narrower steel wall, allowing a greater volume of fluid to pass through it. The flow rate is typically equivalent to that of a needle one gauge larger. This is especially important with very thin needles.
Permanently Attached Needle
Most commonly found in insulin and 'tuberculin' syringes. Permanently attached needles, also known as integral needles, reduce the amount of medication waste and allow accurate mixing of different medications into one syringe.
Regulatory Compliance and Quality System
BD Products comply with the regulatory requirements of the region in which these are sold and manufactured.
Sterility
All products which are labeled as #sterile# and released for sale by BD are certified to be sterile per EN 556-1 Sterilization of Medical Devices as long as the package is unopened and undamaged. This product is sterilized via Cobalt 60 - Irradiation. Sterilization cycle development/validation is performed to 10-6 SAL in accordance with current ISO 11137 guidelines.
Biocompatability
This product has been evaluated in accordance with ISO 10993 "Biological Evaluation of Medical Devices", and complies with all relevant sections.
Pyrogenicity
All products which are labeled as non-pyrogenic and released for sale by BD have been tested per United States Pharmacopeia (USP) chapter (85)- Bacterial Endotoxins Test and meets limits as specified in chapter 161- Transfusion and Infusion Assemblies and Similar Medical Devices.
Quality Control Testing and Release
Representative production samples are collected and inspected in accordance with current applicable product specifications. Inspection records are reviewed and signed off by qualified personnel for product release. The released devices meet applicable BD product specification(s).
Device Characteristics
Proper Injection Technique
Proper injection technique is essential to improve consistency in medication delivery and optimize glycemic control. It includes factors such as:
Proper syringe disposal will help to:
BD 328438 胰岛素注射器3 / 10ml 31Gx5 / 16“ 100 / BX，5 BX / CS
编号BD 328438
销售单位
产品描述
BD 328438-胰岛素注射器3 / 10ml 31Gx5 / 16“ 100 / BX，5 BX / CS
328438-带BD超细针的BD胰岛素注射器8mm x 31G 3/10 mL / cc
BD 328468超细针是一种31针，8毫米（3/10英寸）针头，旨在提供舒适性，准确性和轻松注射性。降低了肌肉痛苦注射的风险。
·更高的功效：功效等同于更长的针头
·患者的选择：超过80％的患者
更少的威胁：对患者的威胁更少
降低风险：降低肌肉注射的风险
·带有永久针头的独立式胰岛素注射器，可与U-100胰岛素配合使用。
·包装中包含最终用户的指导和信息。
主要产品功能
轮毂颜色清除
轮毂材料聚丙烯
集线器类型四舍五入
针规31 G
针规（m）0.25毫米
针头长度（英寸）5/16英寸
针长（m）8毫米
针尖类型3斜角
针型胰岛素
针壁式薄壁
注射器刻度0.3 mL刻度
无菌产品
安全工程安全工程产品
安全设计的具有皮下注射功能的皮下注射针头
灭菌方法伽马射线
乳胶声明非天然橡胶乳胶制成
一次性用品
为什么矮一点更舒服？
大多数人都喜欢短针。它们更舒适，威胁更少，因此更容易开始注射胰岛素。短针还有助于防止注射进肌肉，这可能导致疼痛和血糖控制不佳。
针长（mm）
胰岛素针头有不同的长度。 BD原始针长12.7毫米（1/2英寸），而BD短针长8毫米（5/16英寸）。 BD纳米针4毫米（3/16英寸）和BD迷你针5毫米（5/32英寸）仅在笔式针中可用。为了获得舒适的注射体验，建议并推荐使用较短的针头长度。
针规（G）
规格越高，针越细。例如，32G的针头比31G的针头薄。胰岛素针头有许多规格（G）或厚度可供选择。规格越高，针越细。例如，实际上一根32 G的针比29 G的针更细，更舒适。
薄壁
薄壁：如图所示，薄壁针具有较窄的钢壁，从而允许更多的流体通过。流速通常等于大一号针的流速。这对于非常细的针尤为重要。
永久固定针
最常见于胰岛素和“结核菌素”注射器。永久性连接的针头（也称为一体式针头）减少了药物浪费的数量，并允许将不同药物精确混合到一个注射器中。
法规遵从性和质量体系
BD产品符合其销售和制造地区的法规要求。
不育性
只要包装未打开且未损坏，所有标记为＃sterile＃并由BD出售的产品均已通过EN 556-1医疗器械灭菌认证，可以灭菌。该产品通过60号钴辐照灭菌。根据当前的ISO 11137准则，对10-6 SAL进行灭菌周期开发/验证。
生物相容性
该产品已按照ISO 10993“医疗器械生物学评估”进行了评估，并符合所有相关部分的规定。
热原性
BD标记为无热原并出售的所有产品均已通过美国药典（USP）第（85）章-细菌内毒素测试，并达到第161章-输液和输液组件及类似医疗设备中规定的限制。
质量控制测试与发布
根据当前适用的产品规格，收集并检查代表性的生产样品。检验记录将由合格人员进行审核并签字，以进行产品发布。发行的设备符合适用的BD产品规范。
设备特征
标签包含哪些MRI安全信息？标签不包含MRI安全信息
需要标记为包含天然橡胶胶乳或干燥天然橡胶的设备（21 CFR 801.437）否
标有“非天然橡胶胶乳制成”的设备
一次性使用是
处方使用（Rx）否
场外交易（OTC）否
套件编号
组合产品编号
人细胞，组织或细胞或基于组织的产品（HCT / P）否
正确的注射技术
正确的注射技术对于提高药物输送的一致性和优化血糖控制至关重要。它包括以下因素：
·了解常见的注射部位在哪里
·了解如何轮换网站
·确保始终如一地输送到皮下（脂肪）层
·选择合适的针长
避免注射到肌肉中
为什么适当的处置很重要？
正确的注射器处置
BD 328438 - Insulin Syringe 3/10ml 31Gx5/16" 100/BX, 5 BX/CS
328438 - BD Insulin Syringes with the BD Ultra-Fine needle 8mm x 31G 3/10 mL/cc
BD 328468 Ultra-Fine Needle is a 31-gauge, 8mm (3/10") syringe needle engineered to provide comfort, accuracy and ease in injecting. Reduces the risk of a painful injection in the muscle.
- Greater Efficacy: Efficacy equivalent to longer needles
- Patient Choice: Preffered by over 80% patients
- Less intimidating: Less intimidating for patients
- Reduced Risk: Reduces the risk of intramuscular injection
- Self-contained insulin syringe with permanent needle for use with U-100 insulin.
- Packaging contains end user directions and information.
| Hub Color | Clear |
| Hub Material | Polypropylene |
| Hub Type | Rounded |
| Needle Gauge | 31 G |
| Needle Gauge (m) | 0.25 mm |
| Needle Length (in.) | 5/16 in. |
| Needle Length (m) | 8 mm |
| Needle Tip Type | 3-bevel |
| Needle Type | Insulin |
| Needle Wall Type | Thin Wall |
| Syringe Scale | 0.3 mL graduations |
| Sterile | Sterilized product |
| Safety Engineered | Safety engineered product |
| Safety Engineered Feature | Hypodermic syringe and needle with shielding mechanism |
| Sterilization Method | Gamma radiation |
| Latex Statement | Not made with natural rubber latex |
| Disposable | Disposable product |
Most people prefer short needles. They are more comfortable and less threatening, so its easier to start injecting insulin. Short needles also help prevent injections from going into muscle, which can result in pain and poor blood sugar control.
Needle length (mm)
Insulin needles come in different lengths. BD Original Needles are 12.7 mm (1/2") long, and BD Short Needles are 8 mm (5/16") long. The BD Nano Needle 4mm (3/16") and BD Mini Needle 5mm (5/32") are available only in pen needles. For a comfortable injection experience, shorter needle lengths are recommended and preferred.
Needle gauge (G)
The higher the gauge, the thinner the needle. For example, 32G is thinner than a 31G needle.Insulin needles are available in many gauges (G), or thicknesses. The higher the gauge, the thinner the needle. For example, a 32 G needle is actually thinner and more comfortable than a 29 G needle.
Thin Wall
Thin Wall: As shown in the diagram, the thin wall needle has a narrower steel wall, allowing a greater volume of fluid to pass through it. The flow rate is typically equivalent to that of a needle one gauge larger. This is especially important with very thin needles.
Permanently Attached Needle
Most commonly found in insulin and 'tuberculin' syringes. Permanently attached needles, also known as integral needles, reduce the amount of medication waste and allow accurate mixing of different medications into one syringe.
Regulatory Compliance and Quality System
BD Products comply with the regulatory requirements of the region in which these are sold and manufactured.
Sterility
All products which are labeled as #sterile# and released for sale by BD are certified to be sterile per EN 556-1 Sterilization of Medical Devices as long as the package is unopened and undamaged. This product is sterilized via Cobalt 60 - Irradiation. Sterilization cycle development/validation is performed to 10-6 SAL in accordance with current ISO 11137 guidelines.
Biocompatability
This product has been evaluated in accordance with ISO 10993 "Biological Evaluation of Medical Devices", and complies with all relevant sections.
Pyrogenicity
All products which are labeled as non-pyrogenic and released for sale by BD have been tested per United States Pharmacopeia (USP) chapter (85)- Bacterial Endotoxins Test and meets limits as specified in chapter 161- Transfusion and Infusion Assemblies and Similar Medical Devices.
Quality Control Testing and Release
Representative production samples are collected and inspected in accordance with current applicable product specifications. Inspection records are reviewed and signed off by qualified personnel for product release. The released devices meet applicable BD product specification(s).
Device Characteristics
| What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
| Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437) | No |
| Device labeled as "Not made with natural rubber latex" | No |
| For Single-Use | Yes |
| Prescription Use (Rx) | No |
| Over the Counter (OTC) | No |
| Kit | No |
| Combination Product | No |
| Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) | No |
Proper injection technique is essential to improve consistency in medication delivery and optimize glycemic control. It includes factors such as:
- knowing where the common injection sites are
- understanding how to rotate sites
- ensuring consistent delivery into subcutaneous (fat) layer
- choosing proper needle length
- avoiding injecting into muscle
Proper syringe disposal will help to:
- Store and safely dispose of used syringes and lancets,
- Protect trash collectors from accidental needlesticks,
- Prevent your used syringes from falling into the wrong hands,
- Protect the environment.
| Packaging Level | Shelfpack | Case | Each |
| Quantity | 100 | 500 | 1 |
| Length | 171.45 mm | 438.15 mm | |
| Width | 139.7 mm | 184.15 mm | |
| Height | 84.15 mm | 152.4 mm | |
| Weight | 310.0 g | 1.73 kg | 3.636 g |
BD 328438 胰岛素注射器3 / 10ml 31Gx5 / 16“ 100 / BX，5 BX / CS
编号BD 328438
销售单位
产品描述
BD 328438-胰岛素注射器3 / 10ml 31Gx5 / 16“ 100 / BX，5 BX / CS
328438-带BD超细针的BD胰岛素注射器8mm x 31G 3/10 mL / cc
BD 328468超细针是一种31针，8毫米（3/10英寸）针头，旨在提供舒适性，准确性和轻松注射性。降低了肌肉痛苦注射的风险。
·更高的功效：功效等同于更长的针头
·患者的选择：超过80％的患者
更少的威胁：对患者的威胁更少
降低风险：降低肌肉注射的风险
·带有永久针头的独立式胰岛素注射器，可与U-100胰岛素配合使用。
·包装中包含最终用户的指导和信息。
主要产品功能
轮毂颜色清除
轮毂材料聚丙烯
集线器类型四舍五入
针规31 G
针规（m）0.25毫米
针头长度（英寸）5/16英寸
针长（m）8毫米
针尖类型3斜角
针型胰岛素
针壁式薄壁
注射器刻度0.3 mL刻度
无菌产品
安全工程安全工程产品
安全设计的具有皮下注射功能的皮下注射针头
灭菌方法伽马射线
乳胶声明非天然橡胶乳胶制成
一次性用品
为什么矮一点更舒服？
大多数人都喜欢短针。它们更舒适，威胁更少，因此更容易开始注射胰岛素。短针还有助于防止注射进肌肉，这可能导致疼痛和血糖控制不佳。
针长（mm）
胰岛素针头有不同的长度。 BD原始针长12.7毫米（1/2英寸），而BD短针长8毫米（5/16英寸）。 BD纳米针4毫米（3/16英寸）和BD迷你针5毫米（5/32英寸）仅在笔式针中可用。为了获得舒适的注射体验，建议并推荐使用较短的针头长度。
针规（G）
规格越高，针越细。例如，32G的针头比31G的针头薄。胰岛素针头有许多规格（G）或厚度可供选择。规格越高，针越细。例如，实际上一根32 G的针比29 G的针更细，更舒适。
薄壁
薄壁：如图所示，薄壁针具有较窄的钢壁，从而允许更多的流体通过。流速通常等于大一号针的流速。这对于非常细的针尤为重要。
永久固定针
最常见于胰岛素和“结核菌素”注射器。永久性连接的针头（也称为一体式针头）减少了药物浪费的数量，并允许将不同药物精确混合到一个注射器中。
法规遵从性和质量体系
BD产品符合其销售和制造地区的法规要求。
不育性
只要包装未打开且未损坏，所有标记为＃sterile＃并由BD出售的产品均已通过EN 556-1医疗器械灭菌认证，可以灭菌。该产品通过60号钴辐照灭菌。根据当前的ISO 11137准则，对10-6 SAL进行灭菌周期开发/验证。
生物相容性
该产品已按照ISO 10993“医疗器械生物学评估”进行了评估，并符合所有相关部分的规定。
热原性
BD标记为无热原并出售的所有产品均已通过美国药典（USP）第（85）章-细菌内毒素测试，并达到第161章-输液和输液组件及类似医疗设备中规定的限制。
质量控制测试与发布
根据当前适用的产品规格，收集并检查代表性的生产样品。检验记录将由合格人员进行审核并签字，以进行产品发布。发行的设备符合适用的BD产品规范。
设备特征
标签包含哪些MRI安全信息？标签不包含MRI安全信息
需要标记为包含天然橡胶胶乳或干燥天然橡胶的设备（21 CFR 801.437）否
标有“非天然橡胶胶乳制成”的设备
一次性使用是
处方使用（Rx）否
场外交易（OTC）否
套件编号
组合产品编号
人细胞，组织或细胞或基于组织的产品（HCT / P）否
正确的注射技术
正确的注射技术对于提高药物输送的一致性和优化血糖控制至关重要。它包括以下因素：
·了解常见的注射部位在哪里
·了解如何轮换网站
·确保始终如一地输送到皮下（脂肪）层
·选择合适的针长
避免注射到肌肉中
为什么适当的处置很重要？
正确的注射器处置
所售仪器类商品，保修一年，终身维修。
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