Identity
- Trade Name
- Globe Scientific FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- Urine Collection Plastic Vacuum Tube, Yellow Cap, 13 x 100mm (6.5mL), 100/Box, 10 Boxes/Unit FDA UDI
- Model / Reference
- 3861 FDA UDI
- Description
- Urine Collection Plastic Vacuum Tube, Yellow Cap, 13 x 100mm (6.5mL), 100/Box, 10 Boxes/Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840095606257 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
No
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
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
Globe Scientific by Globe Scientific, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Vacuette — Greiner Bio-One GmbH · Class I
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- BD Vacutainer® Urinalysis Conical Urine Tube — BECTON DICKINSON AND COMPANY · 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
- Globe Scientific, Llc
Sources (1)
- FDA UDI 15414bfe-2833-4d06-a5fe-76b12ff7b204 33 fields · synced May 30, 2026