Syringe

GUDID 10709078013741

Syringe, 3cc Assembled, Luer Slip, No Heparin, Non-Sterile

WESTMED, INC.

Arterial blood sampling kit

• Primary Device ID: 10709078013741
• NIH Device Record Key: 7583fa3b-8bd3-4978-913b-00f22eeaf941
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringe
• Version Model Number: 3314
• 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	00709078013737 [Primary]
GS1	10709078013741 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944941

FDA Product Code

• CBT: Arterial Blood Sampling Kit

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-08
• Device Publish Date: 2022-03-31

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