IMPROVACUTER® Gel & Clot Activator Tube

GUDID 46933395621289

Guangzhou Improve Medical Instruments Co., Ltd.

Evacuated blood collection tube IVD, clot activator/gel separator

• Primary Device ID: 46933395621289
• NIH Device Record Key: 3919ec03-0115-478f-a999-1f8e9c616dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPROVACUTER® Gel & Clot Activator Tube
• Version Model Number: 13x100mm,4ml
• Company DUNS: 530148444
• Company Name: Guangzhou Improve Medical Instruments Co., Ltd.
• Device Count: 100
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06933395621281 [Unit of Use]
GS1	16933395621288 [Primary]
GS1	46933395621289 [Package]; Contains: 16933395621288; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093910

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-26

On-Brand Devices [IMPROVACUTER® Gel & Clot Activator Tube]

• 46933395621357: 16x100mm,8.5ml
• 46933395621340: 16x100mm,8ml
• 46933395621333: 16x100mm,7.5ml
• 46933395621326: 16x100mm,7ml
• 46933395621319: 16x100mm,6ml
• 46933395621302: 13x100mm,6ml
• 46933395621296: 13x100mm,5ml
• 46933395621289: 13x100mm,4ml
• 46933395621272: 13x100mm,3ml
• 46933395621265: 13x75mm,4ml
• 46933395621258: 13x75mm,3.5ml
• 46933395621241: 13x75mm,3ml
• 16933395621868: This is the Conventional Closure Configurations of IMPROVACUTER® Gel &Clot Activator Tube with
• 06974481831436: 13×100mm,5ml
• 06974481831429: 13×100mm,4ml
• 06974481831399: 13×75mm,3.5ml
• 06974481831382: 13×75mm,3ml
• 06974481831498: 16×100mm,8.5ml
• 06974481831481: 16×100mm,8ml
• 06974481831467: 16×100mm,7ml
• 06974481831450: 16×100mm,6ml