Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Specimen mailer kit FDA UDI
- Device Name
- Urine Collection Kit, Prescient Diagnostics Only FDA UDI
- Model / Reference
- CA7000C FDA UDI
- Description
- Urine Collection Kit, Prescient Diagnostics Only FDA UDI
Identifiers
- Catalog Number
- CA7000C FDA UDI
- Primary DI / UDI-DI
- 10885380166808 FDA UDI
- FDA Product Code
- OIB FDA UDI
- GMDN Term
- Specimen mailer kit 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
Yes
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: Specimen mailer kit
Cardinal Health by Aero-Med Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Specimen mailer kit.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- IBSchek — Commonwealth Diagnostics International, Inc. · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- Aero-Med — AERO-MED LLC · Class I
- Aero-Med — AERO-MED LLC · 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
- Aero-Med Llc
Sources (1)
- FDA UDI c95e4d6a-8c9f-413a-8cfc-2b721f5f1474 35 fields · synced May 30, 2026