IMPROVACUTER® Gel & Clot Activator Tube

Basic Information

• Brand Name: IMPROVACUTER® Gel & Clot Activator Tube
• Primary DI: 16933395621868
• Version / Model: 16x100mm,8.5ml
• Company Name: Guangzhou Improve Medical Instruments Co., Ltd.
• Labeler DUNS: 530148444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-04-26
• Public Version: 2
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 9c02f6fd-82db-4b05-bb1b-b7569c19bcd6

Device Description

This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube with the components of Tube, Closure, Clot Activator as well as Serum separating Gel. And the Closure is only made up of Rubber Stopper without Safety Cap. The material of Rubber Stopper is Halogenated butyl rubber.

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: No

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
Primary	16933395621868	GS1
Unit of Use	06933395621649	GS1
Package	46933395621869	GS1		20	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K093910	000