DOMREX™ Safety Blood Collection Set

GUDID 10628032333544

Domrex Pharma Inc

Blood collection set, invasive

• Primary Device ID: 10628032333544
• NIH Device Record Key: 35b3c8c0-7e3b-4031-8508-f185d57c4e17
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOMREX™ Safety Blood Collection Set
• Version Model Number: 23G x 3/4” 12'' Luer Adapter
• 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	00628032333547 [Primary]
GS1	10628032333544 [Package]; Contains: 00628032333547; Package: Case [20 Units]; In Commercial Distribution
GS1	90628032333540 [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™ Safety Blood Collection Set]

• 10628032333551: 25G x 3/4” 12'' Luer Adapter
• 10628032333544: 23G x 3/4” 12'' Luer Adapter
• 10628032333537: 21G x 3/4” 12'' Luer Adapter
• 10628032333445: 23G x 3/4” 12'' Holder
• 10628032333438: 21G x 3/4” 12'' Holder
• 10628032333384: 23G x 3/4” 12''
• 10628032333377: 21G x 3/4” 12''