Identity
- Trade Name
- AlicePDx FDA UDI
- Generic Name
- Home-use sleep apnoea recording system FDA UDI
- Device Name
- AlicePDx MobileLink Cable FDA UDI
- Model / Reference
- Alice PDx MobileLink Cable FDA UDI
- Description
- AlicePDx MobileLink Cable FDA UDI
Identifiers
- Catalog Number
- 1040807 FDA UDI
- Primary DI / UDI-DI
- 00606959049710 FDA UDI
- 510(k) Number
- K090484 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Home-use sleep apnoea recording system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 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
MR Unsafe FDA UDI
Category: Home-use sleep apnoea recording system
AlicePDx by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K090484 also covers:
- ALICE PDX Assembly, BR — Respironics, Inc.
- ALICE PDX Assembly, DOM — Respironics, Inc.
- ALICE PDX Assembly, INTL — Respironics, Inc.
- ALICE PDx — Respironics, Inc.
- Alice PDX Assembly, JP — Respironics, Inc.
- Alice PDx — Respironics, Inc.
- Alice PDx — Respironics, Inc.
- Alice PDx — Respironics, Inc.
- Alice PDx — Respironics, 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 |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (1)
- FDA UDI 2d0f7a1f-c5e0-4421-b4e7-9f5a6736acaf 36 fields · synced Jun 6, 2026