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CoughAssist 70 Series Circuit, Infant, 9ft.
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1098403
Identity
- Trade Name
- CoughAssist 70 Series Circuit, Infant, 9ft. EUDAMEDCoughAssist FDA UDI
- Generic Name
- Positive pressure airway secretion-clearing device FDA UDI
- Device Name
- CoughAssist Class IIa Accessories EUDAMEDCoughAssist 70 Series Circuit, Infant, 9ft. FDA UDI
- Model / Reference
- 1098403 EUDAMEDCoughAssist 70 Series Circuit, Infant, 9ft. FDA UDI
- Description
- CoughAssist 70 Series Circuit, Infant, 9ft. FDA UDI
Identifiers
- Catalog Number
- 1098403 FDA UDI
- Primary DI / UDI-DI
- 00606959021327 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959021327 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
Yes
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 70 Series Circuit, Infant, 9ft. 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-00606959021327 | 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 (3)
- EUDAMED adc2188e-3d76-49fc-b8f5-da571d031eff 61 fields · synced Jun 18, 2026
- FDA UDI c117c880-a026-4fd3-a24f-657e62061c13 37 fields · synced May 30, 2026
- EUDAMED 4252b8d8-9fd2-4e1c-aba6-e9d9cb0f5c6a 61 fields · synced Jun 11, 2026