IMPROVACUTER® Gel & Clot Activator Tube

Basic Information

• Brand Name: IMPROVACUTER® Gel & Clot Activator Tube
• Primary DI: 16974481831433
• Version / Model: 13×100mm,5ml
• Company Name: Guangzhou Improve Medical Instruments Co., Ltd.
• Labeler DUNS: 554555378
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-06-24
• Public Version: 1
• Public Version Date: 2022-07-04
• Public Version Status: New
• Public Device Record Key: 7eebd06e-5f26-4234-8b72-25291c9aac77

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
41128	Evacuated blood collection tube IVD, clot activator/separator	A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator, and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06974481831436	GS1
Primary	16974481831433	GS1
Package	46974481831434	GS1		10	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K093910	000