BD 309646 Luer-Lok Syringe sterile, single use 5 mL 125 EA

309646 – 5 mL BD Luer-Lok Syringe Sterile, Single use
Sterile
Do Not Reuse
Do Not Reshield Used Needles
Not made with natural rubber latex
Not made with DEHP
BD Luer-Lok Tip

Bring Security to Critical Applications
BD Luer-Lok thread: The BD Luer-Lok thread provides a secure connection.
Plunger rod design: Each disposable syringe features a tapered plunger rod for ease of aspiration and a positive plunger rod stop.
Ease of use: BD syringes feature a clear barrel with bold scale markings.
Graduation: The 5-mL syringe’s scale has 1/5 mL graduation.
Key Product Features
Parenteral Parenteral product
Pyrogen Free Product is pyrogen free
Syringe Tip Orientation Concentric
Syringe Tip Type BD Luer-Lok
Syringe Scale 0.2 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,EO
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.

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 Gamma. Sterilization cycle development/validation is performed to 10-6SAL 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 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) Yes
Over the Counter (OTC) No
Kit No
Combination Product No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P) No