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Ca70 Series, Circuit, Adult Lg., 6ft
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 1090834
Identity
- Trade Name
- CoughAssist E70 Accessories EUDAMEDCoughAssist FDA UDI
- Generic Name
- Positive pressure airway secretion-clearing device FDA UDI
- Device Name
- CA70 SERIES,CIRCUIT,ADULT LG.,6FT EUDAMEDCoughAssist 70 Series Circuit, Adult Large, 6ft FDA UDI
- Model / Reference
- 1090834 EUDAMEDCoughAssist 70 Series Circuit, Adult Large, 6ft FDA UDI
- Description
- CoughAssist 70 Series Circuit, Adult Large, 6ft FDA UDI
Identifiers
- Catalog Number
- 1090834 FDA UDI
- Primary DI / UDI-DI
- 00606959021235 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959021235 EUDAMED
- 510(k) Number
- K121955 FDA UDI
- FDA Product Code
- NHJ FDA UDI
- EMDN Code
- Z1203010504 ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORS EUDAMED
- GMDN Term
- Positive pressure airway secretion-clearing device FDA UDI
Classification
- Device Class
- Class IIb 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Ca70 Series, Circuit, Adult Lg., 6ft by Respironics, Inc. — Class IIb — 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-00606959021235 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 791828b9-b26e-4414-a70e-5cb16b654b45 61 fields · synced Jul 10, 2026
- FDA UDI 5881c3ba-f809-471e-9eaf-cd21f43a0d54 37 fields · synced May 30, 2026
- EUDAMED 6b95517b-a753-4aee-890c-3c3897f37241 61 fields · synced Jul 10, 2026