Identity
- Trade Name
- Specimen Collection Swab FDA UDI
- Generic Name
- Oral/upper respiratory tract specimen collection swab FDA UDI
- Device Name
- 3" Polyester Swab FDA UDI
- Model / Reference
- SW0402X3 FDA UDI
- Description
- 3" Polyester Swab FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810050852593 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- Oral/upper respiratory tract specimen collection swab FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6025 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Specimen Collection Swab by Typenex Medical, LLC — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Typenex Medical, LLC
Sources (1)
- FDA UDI e9e88c6a-ac80-4535-ae19-cc4d9249f8c2 34 fields · synced May 30, 2026