Identity
- Trade Name
- Vacuette FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, non-ridged FDA UDI
- Model / Reference
- 455007 FDA UDI
- Description
- VACUETTE® TUBE 10 ml Z Urine No Additive 16x100 yellow cap-yellow ring, Round Base, non-ridged FDA UDI
Identifiers
- Catalog Number
- 455007 FDA UDI
- Primary DI / UDI-DI
- 29120017576048 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Evacuated urine specimen container IVD, no additive 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
Yes
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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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, no additive
Vacuette by Greiner Bio-One GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated urine specimen container IVD, no additive.
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- BD Vacutainer® Z (No Additive) Plus Urine Tube — Becton, Dickinson U.K. Limited · Class I
- V-Monovette® Urine Z 6ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- V-Monovette® Urine Z 9.5ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- BD Vacutainer® Urinalysis Conical Urine Tube — BECTON DICKINSON AND COMPANY · Class I
- Xpeedy — CURA DIAGNOSTICS INC. · Class I
- Xpeedy — CURA DIAGNOSTICS INC. · Class I
- V-Monovette® Urine Z 4ml — Sarstedt Aktiengesellschaft & Co.KG · 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 b357d711-fbc5-444e-ae8b-52c823bd3008 35 fields · synced Jun 1, 2026