Identity
- Trade Name
- Avaline Medical NJ LLC FDA UDI
- Generic Name
- Urine specimen collection kit IVD FDA UDI
- Device Name
- 1 Specimen Collector Pan FDA UDI
- Model / Reference
- mc6050.2 FDA UDI
- Description
- 1 Specimen Collector Pan FDA UDI
Identifiers
- Catalog Number
- mc6050.2 FDA UDI
- Primary DI / UDI-DI
- 00638317689948 FDA UDI
- FDA Product Code
- NNI 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
- Not 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Avaline Medical NJ LLC by Avaline Medical NJ Limited Liability Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Avaline Medical NJ Limited Liability Company
Sources (1)
- FDA UDI afefbb52-49f3-404c-ba2b-23dfdb007b7c 36 fields · synced May 30, 2026