Breathing hose 22/22 (A)25
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Atemschlauch 22/22 (A) 25 EUDAMEDBreathing hose 22/22 (A)25 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Model / Reference
- 8604916 EUDAMEDFDA UDI208044PK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675131076 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208044PK19Z000B8 EUDAMED
- Direct Marketing DI
- 04048675131076 EUDAMED
- FDA Product Code
- BZO FDA UDICAI FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI868.5240 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ventilator breathing circuit, reusable
Breathing hose 22/22 (A)25 by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Ventilator breathing circuit, reusable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 5c00ec31-6d92-46bd-b8cf-a2205a84e6d8 33 fields · synced Jul 8, 2026
- EUDAMED 4cfbb202-1edf-460c-888d-d6358aa14d61 61 fields · synced Jun 18, 2026