Identity
- Trade Name
- System One FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- System One Heated Humidifier, International FDA UDI
- Model / Reference
- System One Heated Humidifier, INTL FDA UDI
- Description
- System One Heated Humidifier, International FDA UDI
Identifiers
- Catalog Number
- IN6HFLG FDA UDI
- Primary DI / UDI-DI
- 00606959032095 FDA UDI
- 510(k) Number
- K113068 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heated respiratory humidifier
System One by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heated respiratory humidifier.
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- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
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Cleared under the same submission
K113068 also covers:
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, Inc.
- REMstar System One 60 Series — Respironics, 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 |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA UDI ed36c689-a69f-4492-bf67-52d023b9004c 37 fields · synced Jun 1, 2026