Identity
- Trade Name
- Mediplus FDA UDI
- Generic Name
- Capnography oxygen mask FDA UDI
- Device Name
- Capnomask™ Paediatric Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm FDA UDI
- Model / Reference
- A202Px-M FDA UDI
- Description
- Capnomask™ Paediatric Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055140704023 FDA UDI
- 510(k) Number
- K131339 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Capnography oxygen mask FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 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: Capnography oxygen mask
Mediplus by Mediplus , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131339 also covers:
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
- Mediplus — Mediplus , Ltd.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mediplus , Ltd.
Sources (1)
- FDA UDI 3b316f21-aad3-48c6-95e6-30e5136608e8 35 fields · synced Jun 6, 2026