Identity
- Trade Name
- Xpeedy FDA UDI
- Generic Name
- Evacuated urine specimen container IVD, no additive FDA UDI
- Device Name
- Xpeedy Vaccum Urine Collection Tube 13 mm x 100 mm, White Cap FDA UDI
- Model / Reference
- Vaccum Urine Collection Tube White Cap FDA UDI
- Description
- Xpeedy Vaccum Urine Collection Tube 13 mm x 100 mm, White Cap FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860012318209 FDA UDI
- FDA Product Code
- MPQ FDA UDI
- GMDN Term
- Evacuated urine specimen container IVD, no additive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3260 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
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
Xpeedy by Cura Diagnostics Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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
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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
- Cura Diagnostics Inc.
Sources (1)
- FDA UDI 331fcc8f-5e9b-4fcb-b0df-f1b9ff1f6b6a 33 fields · synced Jun 6, 2026