DOMREX™ Blood Collection Set

GUDID 10628032400031

Domrex Pharma Inc

Blood collection set, invasive

• Primary Device ID: 10628032400031
• NIH Device Record Key: 195391f2-1f70-4ce8-8568-e05b89c63e3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMREX™ Blood Collection Set
• Version Model Number: 21G x 3/4” 12''
• Company DUNS: 242411127
• Company Name: Domrex Pharma Inc
• Device Count: 50
• 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	00628032400034 [Primary]
GS1	10628032400031 [Package]; Contains: 00628032400034; Package: Case [20 Units]; In Commercial Distribution
GS1	90628032400037 [Unit of Use]

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: 2024-01-29
• Device Publish Date: 2024-01-19

On-Brand Devices [DOMREX™ Blood Collection Set]

• 10628032400048: 23G x 3/4'' 12''
• 10628032400031: 21G x 3/4” 12''