BD 309620 Syringe 2oz Catheter Tip w/o Needle Shelf Pack 160/CS

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Description

BD 309620 Syringe 2oz Catheter Tip w/o Needle Shelf Pack 160/CS

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.

30ml syringe

Catheter tip

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

Key Product Features

CE Mark Product is CE-marked
Parenteral Parenteral product
Pyrogen Free Product is pyrogen free
Syringe Tip Orientation Concentric
Syringe Tip Type Catheter tip
Syringe Scale 1 mL graduations
Total Shelf Life 1825
Sterile Sterilized product
Volumetric Accuracy +/- 5% *for 1ml or smaller,accuracy below 0.2ml is+/- 0.07ml
Sterilization Method Radiation
BPA Free Not made with BPA
DEHP Free Not made with DEHP
Latex Statement Not made with natural rubber latex
PVC Free Not made with PVC
Disposable Disposable product
Single Use Product 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-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

Product Packaging Information

Packaging Level Shelfpack Case Each
Quantity 40 160 1
Length 353.0 mm 523.24 mm
Width 261.0 mm 347.98 mm
Height 169.0 mm 325.12 mm
Weight 1.894 kg 7.575 kg 47.344 g

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