Identity
- Trade Name
- Passive Heated Breathing Circuit Kit FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- (1) Adult Single Limb Passive Heated Wire Circuit - Fisher & Paykel OEM # RT114 with (1) Swivel Exhalation Port for Ventilator Circuits & CPAP (Comparable to Respironics 332113) FDA UDI
- Model / Reference
- VC1114-KIT FDA UDI
- Description
- (1) Adult Single Limb Passive Heated Wire Circuit - Fisher & Paykel OEM # RT114 with (1) Swivel Exhalation Port for Ventilator Circuits & CPAP (Comparable to Respironics 332113) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530104153 FDA UDI
- FDA Product Code
- BZE FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5270 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heated respiratory humidifier
Passive Heated Breathing Circuit Kit by SUNSET HEALTHCARE SOLUTIONS, 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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- A Series Heated Humidifier — Respironics, Inc. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI f7479b1a-0bbc-4995-878b-b9b035decd3c 34 fields · synced Jun 8, 2026