Identity
- Trade Name
- IMPROVACUTER® Gel & Clot Activator Tube FDA UDI
- Generic Name
- Evacuated blood collection tube IVD, clot activator/separator FDA UDI
- Model / Reference
- 16×100mm,8.5ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 16974481831495 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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- Vacuette — Greiner Bio-One GmbH · Class II
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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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangzhou Improve Medical Instruments Co., Ltd.
Sources (1)
- FDA UDI 0906cfef-7e06-4ce6-9770-c30a85776bc4 33 fields · synced Jun 7, 2026