HEPRO.US - Gel & Clot Activator Tube

Basic Information

• Brand Name: HEPRO.US - Gel & Clot Activator Tube
• Primary DI: 00850578007631
• Version / Model: Pack Gel Clot Test Tubes
• Company Name: HEPRO.US INC.
• Labeler DUNS: 080061451
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-06-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: afb15344-46df-4ea1-99d8-363b54fbf9e9

Device Description

Gel & Clot Activator Tube, with serum for determinations in chemistry and serology. Pack of 100

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14189	Culture tube	A sterile glass or plastic tube-like container used to hold a culture specimen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850578007631	GS1
Unit of Use	85057800763101	GS1