Identity
- Trade Name
- VACUETTE FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, preservative FDA UDI
- Device Name
- Urine STB Set VACUETTE® Urine STB Tube + Urine Transfer Device (455023+450751), single-packed, conical base, 9 ml, 16x100 FDA UDI
- Model / Reference
- 453045 FDA UDI
- Description
- Urine STB Set VACUETTE® Urine STB Tube + Urine Transfer Device (455023+450751), single-packed, conical base, 9 ml, 16x100 FDA UDI
Identifiers
- Catalog Number
- 453045 FDA UDI
- Primary DI / UDI-DI
- 19120126131452 FDA UDI
- FDA Product Code
- NNI FDA UDI
- GMDN Term
- Evacuated urine specimen container IVD, preservative FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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 urine specimen container IVD, preservativeUrine transfer IVD, non-sterile
Vacuette by Greiner Bio-One GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine transfer IVD, non-sterile.
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- UriCap Female 1 Set SX — TILLA CARE LTD · Class I
- Extension Tube — TILLA CARE LTD · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- UriCap Base kit box of 30 — TILLA CARE LTD · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Greiner Bio-One GmbH
Sources (1)
- FDA UDI 19ba0888-30c1-4296-93bf-17f92b13f8f5 35 fields · synced May 30, 2026