Identity
- Trade Name
- Hose FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Device Name
- HOSE,22mm-18IN,NON-AUTOCLAV EUDAMED22 mm Patient Tubing, 18in, non-autoclaveable tubing FDA UDI
- Model / Reference
- 1008198 EUDAMED00 FDA UDI
- Description
- 22 mm Patient Tubing, 18in, non-autoclaveable tubing FDA UDI
Identifiers
- Catalog Number
- 1008198 FDA UDI
- Primary DI / UDI-DI
- 00606959043497 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959043497 EUDAMED
- FDA Product Code
- BYX FDA UDI
- EMDN Code
- Z12030103 PULMONARY VENTILATORS FOR NON–HOSPITAL USE EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5860 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HOSE, 22mm-18IN, NON-AUTOCLAV 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-00606959043497 | 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 ee2e325e-26f7-4568-a5c6-fd1c173869e9 61 fields · synced Jun 18, 2026
- FDA UDI 0b3951a4-93ff-4bf9-b4bf-a9a75ec419cc 36 fields · synced May 30, 2026