BD #309620 - Syringe 2oz Catheter Tip w/o Needle Shelf Pack 40/Bx, 4 BX/CA

BD #309620 - Syringe 2oz Catheter Tip w/o Needle Shelf Pack 40/Bx, 4 BX/CA
CIA1119338
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Product Description

BD Part #309620 - Syringe 2oz Catheter Tip w/o Needle Shelf Pack 40/Bx, 4 BX/CA

60 mL BD Catheter Tip Syringe Only (with Tip Shield)

309620 - 2 oz. 60 mL BD Catheter Tip Syringe sterile, single use

BD conventional syringes are available with and without an attached needle. BD syringe-needle combinations feature a clear barrel with a bold scale. Disposable syringes with a BD Luer-Lok tip, luer slip tip or eccentric luer slip tip can be fitted with either a conventional needle or safety needle.

Catheter tip

The catheter tip is used for flushing catheters, gastostomy tubes and other devices.

Key Product Features

CE MarkProduct is CE-marked
ParenteralParenteral product
Pyrogen FreeProduct is pyrogen free
Syringe Tip OrientationConcentric
Syringe Tip TypeCatheter tip
Syringe Scale1 mL graduations
Total Shelf Life1825
SterileSterilized product
Volumetric Accuracy+/- 5% *for 1ml or smaller,accuracy below 0.2ml is+/- 0.07ml
Sterilization MethodRadiation
BPA FreeNot made with BPA
DEHP FreeNot made with DEHP
Latex StatementNot made with natural rubber latex
PVC FreeNot made with PVC
DisposableDisposable product
Single UseProduct is for single use only

Regulatory Compliance and Quality System

BD Products comply with the regulatory requirements of the region in which these are sold and manufactured.

CE-marked

BD Products which are CE marked comply with Medical Devices Directive 93/42/EEC and are manufactured within production facilities that comply with the international standard ISO 13485: Quality Systems - Medical Devices - Requirements For regulatory purposes.

Sterility

All products which are labeled as #sterile# and released for sale by BD are certified to be sterile as long as the package is unopened and undamaged. For those products labeled #sterile fluid path#, only the fluid path is sterile.

This product is primarily sterilized via E-beam. Sterilization cycle development/validation is performed to 10-6SAL in accordance with current ISO 11137 guidelines.

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 specifications.

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-UseYes
Prescription Use (Rx)No
Over the Counter (OTC)No
KitNo
Combination ProductNo
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)No

Product Packaging Information

Packaging LevelShelfpackCaseEach
Quantity401601
Length353.0 mm523.24 mm
Width261.0 mm347.98 mm
Height169.0 mm325.12 mm
Weight1.894 kg7.575 kg47.344 g