Identity
- Trade Name
- Mawi DNA Technologies FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
- Device Name
- NextSWAB, 2-pack FDA UDI
- Model / Reference
- NextSWAB-2 FDA UDI
- Description
- NextSWAB, 2-pack FDA UDI
Identifiers
- Catalog Number
- NextSWAB-2 FDA UDI
- Primary DI / UDI-DI
- 00850040712179 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Oral/upper respiratory tract specimen collection swab IVD
Mawi DNA Technologies by Mawi DNA Technologies, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oral/upper respiratory tract specimen collection swab 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 |
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Manufacturer
- Manufacturer
- Mawi DNA Technologies, LLC
Sources (1)
- FDA UDI 10612e6c-29ed-4059-ae46-3b478492fd11 35 fields · synced Jun 1, 2026