Identity
- Trade Name
- APEX FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- iCH Sense FDA UDI
- Model / Reference
- 9S-007001 FDA UDI
- Description
- iCH Sense FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04713025000127 FDA UDI
- 510(k) Number
- K150111 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Home CPAP unit 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: Home CPAP unit
Apex by Wellell Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150111 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wellell Inc.
Sources (1)
- FDA UDI 35c3266f-c4d0-4001-bbfd-fa1af2c3a205 34 fields · synced Jun 8, 2026