Identity
- Trade Name
- ezRIP FDA UDI
- Generic Name
- Polysomnograph FDA UDI
- Device Name
- ezRIP, Abdomen, 1.5, 84 inch, Alice FDA UDI
- Model / Reference
- ezRIP, Abdomen, 1.5, 84 inch, Alice FDA UDI
- Description
- ezRIP, Abdomen, 1.5, 84 inch, Alice FDA UDI
Identifiers
- Catalog Number
- 1094110 FDA UDI
- Primary DI / UDI-DI
- 00606959010680 FDA UDI
- 510(k) Number
- K013905 FDA UDI
- FDA Product Code
- MNR FDA UDI
- GMDN Term
- Polysomnograph 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polysomnograph
ezRIP by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K013905 also covers:
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — Respironics, Inc.
- ezRIP — 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 ef48bece-31e4-452f-9203-3a442649c70e 37 fields · synced May 30, 2026