Identity
- Trade Name
- IMPROVACUTER® Gel & Clot Activator Tube FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, clot activator/separator FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 16x100mm,8.5ml FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16933395621868 FDA UDI
- 510(k) Number
- K093910 FDA UDI
- FDA Product Code
- JKA FDA UDI
- GMDN Term
- Evacuated blood collection tube IVD, clot activator/separator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1675 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Evacuated blood collection tube IVD, clot activator/separator
IMPROVACUTER® Gel & Clot Activator Tube by Guangzhou Improve Medical Instruments Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K093910 also covers:
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
- IMPROVACUTER® Gel & Clot Activator Tube — Guangzhou Improve Medical Instruments Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 9c02f6fd-82db-4b05-bb1b-b7569c19bcd6 34 fields · synced May 30, 2026