DOMREX™ Syringe

GUDID 10628032000057

Domrex Pharma Inc

General-purpose syringe, single-use

• Primary Device ID: 10628032000057
• NIH Device Record Key: 49327bfd-244c-4a77-beea-09832ecef7e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMREX™ Syringe
• Version Model Number: 5ML
• Company DUNS: 242411127
• Company Name: Domrex Pharma 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628032000050 [Primary]
GS1	10628032000057 [Package]; Contains: 00628032000050; Package: [4 Units]; In Commercial Distribution
GS1	90628032000053 [Unit of Use]

FDA Product Code

• FMF: Syringe, Piston

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: 2024-01-29
• Device Publish Date: 2024-01-21

On-Brand Devices [DOMREX™ Syringe]

• 10628032000101: 10ML
• 10628032000057: 5ML
• 10628032000033: 3ML
• 10628032000019: 1ml LDS