Identity
- Trade Name
- CoughAssist FDA UDI
- Generic Name
- Positive pressure airway secretion-clearing device FDA UDI
- Device Name
- CoughAssist, Face Mask, Infant FDA UDI
- Model / Reference
- CoughAssist, Facemask, Infant FDA UDI
- Description
- CoughAssist, Face Mask, Infant FDA UDI
Identifiers
- Catalog Number
- 1044190 FDA UDI
- Primary DI / UDI-DI
- 00606959020498 FDA UDI
- 510(k) Number
- K121955 FDA UDI
- FDA Product Code
- NHJ FDA UDI
- GMDN Term
- Positive pressure airway secretion-clearing device 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Positive pressure airway secretion-clearing device
CoughAssist by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121955 also covers:
- ATOS — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — Respironics, Inc.
- CoughAssist — 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 62974891-8ff2-44e1-a902-3bdb14dfc1ef 37 fields · synced May 31, 2026