Identity
- Trade Name
- Mswab® FDA UDI
- Generic Name
- General specimen collection kit FDA UDI
- Device Name
- MSwab Kit 1,6 mL Collection transport and preservation system for Gram positive aerobic & facultative anaerobic bacteria & HSV1/HSV2 FDA UDI
- Model / Reference
- 07007248190 FDA UDI
- Description
- MSwab Kit 1,6 mL Collection transport and preservation system for Gram positive aerobic & facultative anaerobic bacteria & HSV1/HSV2 FDA UDI
Identifiers
- Catalog Number
- 07007248190 FDA UDI
- Primary DI / UDI-DI
- 38053326006198 FDA UDI
- 510(k) Number
- K121039 FDA UDI
- FDA Product Code
- JTW FDA UDI
- GMDN Term
- General specimen collection kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2900 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
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
No
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 specimen collection kit
Mswab® by Copan Italia Spa — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General specimen collection kit.
- TUD NA CITRATE 0.109M 3ML — TUD SDN BHD · Class A
- GN Broth — Copan Italia S.P.A. · Class A
- Centurion — Centurion Medical Products · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- LBM LIM Broth — Copan Italia S.P.A. · Class A
- Centurion — Centurion Medical Products · Class I
- Probówki o poj. 11ml, z MEDOPLASTU, z granulatem do szybkiego wykrzepiania, z nalepką — MEDLAB-PRODUCTS Sp. z o.o. · Class A
- KaiBiLi Extended ViralTrans Saline — Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. · Class I
Cleared under the same submission
K121039 also covers:
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
- Copan Italia Spa
Sources (1)
- FDA UDI 40f22dc1-3737-453f-8efb-e922e97b5d63 35 fields · synced May 30, 2026