Identity
- Trade Name
- Aero-Med FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- 24 Hour Urine Collection Kit, Hennepin Healthcare Only FDA UDI
- Model / Reference
- CA24800 FDA UDI
- Description
- 24 Hour Urine Collection Kit, Hennepin Healthcare Only FDA UDI
Identifiers
- Catalog Number
- CA24800 FDA UDI
- Primary DI / UDI-DI
- 10885380174810 FDA UDI
- FDA Product Code
- OIB FDA UDI
- GMDN Term
- Urine specimen collection kit IVD 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
Yes
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: Urine specimen collection kit IVD
Aero-Med by Aero-Med Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urine specimen collection kit IVD.
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- SureStep Vacutainer Urine Sampling Kit — C. R. Bard, Inc. · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability Company · Class I
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class I
- US Biotek Laboratories — US BIOTEK LABORATORIES · Class I
- Fisherbrand — FISHER SCIENTIFIC COMPANY L.L.C. · Class I
- Avaline Medical NJ LLC — Avaline Medical NJ Limited Liability 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aero-Med Llc
Sources (1)
- FDA UDI 77fb4234-b8af-4e49-beb5-7e9df37c14f1 34 fields · synced Jun 1, 2026