Identity
- Trade Name
- Thermalite Heated CPAP Tube FDA UDI
- Generic Name
- Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
- Device Name
- Heated CPAP Tube for DreamStation and DreamStation 2 FDA UDI
- Model / Reference
- CTUB-06H15DS FDA UDI
- Description
- Heated CPAP Tube for DreamStation and DreamStation 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00819989011576 FDA UDI
- 510(k) Number
- K241268 FDA UDI
- FDA Product Code
- BZE FDA UDIBZD FDA UDI
- GMDN Term
- Inspiratory/expiratory limb respiratory tubing, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5270 FDA UDI868.5905 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
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: Inspiratory/expiratory limb respiratory tubing, reusable
Thermalite Heated CPAP Tube by Exceleron Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Exceleron Medical, Llc
Sources (1)
- FDA UDI 8f8a7833-ce9a-452f-aa7d-837e083714ac 34 fields · synced May 30, 2026