Identity
- Trade Name
- Transcend FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Model / Reference
- 3 miniCPAP Auto Service Unit FDA UDI
Identifiers
- Catalog Number
- 503105 FDA UDI
- Primary DI / UDI-DI
- M9505031050 FDA UDI
- 510(k) Number
- K132127 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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 190 Millimeter FDA UDIWidth — 95 Millimeter FDA UDIHeight — 94 Millimeter FDA UDI
Category: Home CPAP unit
Transcend by Somnetics International, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home CPAP unit.
- DreamStation — Respironics, Inc. · Class II
- REMstar System One 60 Series — Respironics, Inc. · Class II
- Eclipse Vent Filter Replacement Pack — BLEEP, LLC · Class II
- DreamStation — Respironics, Inc. · Class II
- AIRSENSE — RESMED PTY LTD · Class II
- DreamStation — Respironics, Inc. · Class II
- DreamStation — Respironics, Inc. · Class II
- REMstar System One 60 Series — Respironics, Inc. · Class II
Cleared under the same submission
K132127 also covers:
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, INC
- Transcend — SOMNETICS INTERNATIONAL, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Somnetics International, Inc
Sources (1)
- FDA UDI 41e70290-cfbf-4e81-b03f-469995480c74 37 fields · synced May 30, 2026