Identity
- Trade Name
- LabChoice Specimen Bags, 12" x 15", 1.8 mil FDA UDI
- Generic Name
- Contaminated waste bag FDA UDI
- Model / Reference
- 8022 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840117333413 FDA UDI
- FDA Product Code
- NNK FDA UDINNI FDA UDI
- GMDN Term
- Contaminated waste bag 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Contaminated waste bagBreath specimen container adaptor IVD
LabChoice Specimen Bags, 12" x 15", 1.8 mil by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Breath specimen container adaptor IVD.
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
- Dynarex Corp.
Sources (1)
- FDA UDI e01fe9c2-2d0e-47e9-a34c-46e11506de4c 32 fields · synced May 30, 2026