Identity
- Trade Name
- BD Vacutainer® Urinalysis Conical Urine Tube FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- TUBE URIN PLC 16X100 8.0 CONI UA YEL FDA UDI
- Model / Reference
- 364980 FDA UDI
- Description
- TUBE URIN PLC 16X100 8.0 CONI UA YEL FDA UDI
Identifiers
- Catalog Number
- 364980 FDA UDI
- Primary DI / UDI-DI
- 30382903649809 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
BD Vacutainer® Urinalysis Conical Urine Tube by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Evacuated urine specimen container IVD, no additive.
- V-Monovette® Urine Z 10ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- 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
- Vacuette — Greiner Bio-One GmbH · Class I
- V-Monovette® Urine Z 9.5ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- Vacuette — Greiner Bio-One GmbH · Class I
- VACUETTE — Greiner Bio-One GmbH · Class I
- Vacuette — Greiner Bio-One GmbH · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI 70b5960e-1ea3-495d-814c-a267e13c3cda 35 fields · synced May 30, 2026