Identity
- Trade Name
- CoughAssist, Mouthpiece EUDAMEDCoughAssist FDA UDI
- Generic Name
- Positive pressure airway secretion-clearing device FDA UDI
- Device Name
- CoughAssist Class IIa Accessories EUDAMEDCoughAssist, Mouthpiece FDA UDI
- Model / Reference
- 1044821 EUDAMEDCoughAssist, Mouthpiece FDA UDI
- Description
- CoughAssist, Mouthpiece FDA UDI
Identifiers
- Catalog Number
- 1044821 FDA UDI
- Primary DI / UDI-DI
- 00606959041530 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959041530 EUDAMED
- 510(k) Number
- K121955 FDA UDI
- FDA Product Code
- NHJ FDA UDI
- EMDN Code
- R05010301 SINGLE-CHAMBER MUCOUS MEMBRANE ASPIRATORS EUDAMED
- GMDN Term
- Positive pressure airway secretion-clearing device FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
CoughAssist, Mouthpiece by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959041530 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (2)
- EUDAMED 5db64226-f82d-402b-83a9-20a50b642d4a 61 fields · synced Jun 17, 2026
- FDA UDI 42a6dfe0-3184-418d-99cf-c9bbdba1fb21 37 fields · synced May 30, 2026