Atellica® VTR Syringes

GUDID 10709078013338

1mL Vented Luer Slip Syringe, 25g x 5/8" Needle, ~25IU Balanced Heparin, Vented Tip Cap, Q-Cork (Private Label)

WESTMED, INC.

Arterial blood sampling kit

• Primary Device ID: 10709078013338
• NIH Device Record Key: 5320b07f-fd72-49ab-8ca7-608bba943453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Atellica® VTR Syringes
• Version Model Number: 11561342
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078013324 [Primary]
GS1	10709078013338 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931924

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-08
• Device Publish Date: 2022-02-28

On-Brand Devices [Atellica® VTR Syringes]

• 10709078013536: 3mL Vented, Luer Slip Syringe, 23g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Ti
• 10709078013512: 3mL Vented, Luer Lock Syringe, 23g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented T
• 10709078013499: 3mL Vented, Luer Lock Syringe, 22g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Ti
• 10709078013475: 3mL Vented Luer Slip Syringe, 22g x 1" Safety Tip, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip
• 10709078013451: 3mL Vented Luer Slip Syringe 22g x 1" Needle, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap,
• 10709078013437: 3mL A-Line Aspirating Luer Lock Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Priv
• 10709078013413: 3mL A-Line Aspirating Luer Slip Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Priv
• 10709078013390: 3mL Vented Luer Lock Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
• 10709078013376: 3mL Vented Luer Slip Syringe, (~50IU)16.7IU/mL Balanced Heparin, Vented Tip Cap (Private Label)
• 10709078013352: 1mL Vented Luer Slip Syringe, 25g x 5/8" Safety Tip, ~25IU Balanced Heparin, Vented Tip Cap (Pri
• 10709078013338: 1mL Vented Luer Slip Syringe, 25g x 5/8" Needle, ~25IU Balanced Heparin, Vented Tip Cap, Q-Cork
• 10709078013314: 1mL A-Line Aspirating Luer Slip Syringe, ~25IU Balanced Heparin, Vented Tip Cap (Private Label)
• 10709078013291: 1mL Vented Luer Slip Syringe, ~25IU Balanced Heparin, Vented Tip Cap (Private Label)