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Heated CPAP Tube for DreamStation Series and PR System One
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Heated CPAP Tube for DreamStation Series and PR System One FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- Heated CPAP Tube for DreamStation Series and PR System One- 6ft Light Gray Smoothbore CPAP Tubing - Slim Style FDA UDI
- Model / Reference
- TUB006SSRP FDA UDI
- Description
- Heated CPAP Tube for DreamStation Series and PR System One- 6ft Light Gray Smoothbore CPAP Tubing - Slim Style FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530070670 FDA UDI
- 510(k) Number
- K201418 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Heated respiratory humidifier
Heated CPAP Tube for DreamStation Series and PR System One by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Heated respiratory humidifier.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
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- A Series Heated Humidifier — Respironics, Inc. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K201418 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 II | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI be5588c6-ab3a-4cbc-846a-8c7a2cb3817e 35 fields · synced May 30, 2026