Identity
- Trade Name
- Fisher and Paykel Healthcare FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- HUMIDIFIER MR810 230V EN / FR / SP FDA UDI
- Model / Reference
- MR810AEU FDA UDI
- Description
- HUMIDIFIER MR810 230V EN / FR / SP FDA UDI
Identifiers
- Catalog Number
- MR810AEU FDA UDI
- Primary DI / UDI-DI
- 09420012411815 FDA UDI
- 510(k) Number
- K131957 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Heated respiratory humidifier
Fisher and Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Heated respiratory humidifier.
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Cleared under the same submission
K131957 also covers:
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.
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
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI 1d26ed0e-811c-4752-988d-f347d3bf9be8 37 fields · synced May 31, 2026