Identity
- Trade Name
- BBL™ CultureSwab™ FDA UDI
- Generic Name
- General-purpose absorbent tip applicator/swab, single-use FDA UDI
- Device Name
- CultureSwab Sterile Double Swab FDA UDI
- Model / Reference
- 220135 FDA UDI
- Description
- CultureSwab Sterile Double Swab FDA UDI
Identifiers
- Catalog Number
- 220135 FDA UDI
- Primary DI / UDI-DI
- 38053326002091 FDA UDI
- FDA Product Code
- KXG FDA UDI
- GMDN Term
- General-purpose absorbent tip applicator/swab, single-use 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose absorbent tip applicator/swab, single-use
BBL™ CultureSwab™ by Copan Italia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General-purpose absorbent tip applicator/swab, single-use.
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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
- Copan Italia Spa
Sources (1)
- FDA UDI 4c9e70e4-70a4-46cc-96e3-484508848e4f 34 fields · synced May 30, 2026