Corrugated hose 10/10 (N/P) 28
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Faltenschlauch 10/10 (N/P) 28 EUDAMEDCorrugated hose 10/10 (N/P) 28 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Model / Reference
- 8402041 EUDAMEDFDA UDI208044PK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675026488 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208044PK19Z000B8 EUDAMED
- Direct Marketing DI
- 04048675026488 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
No
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Ventilator breathing circuit, reusable
Corrugated hose 10/10 (N/P) 28 by Drägerwerk AG & Co. KGaA — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 d7a78d22-4750-41bc-a95a-d69e5e37906c 33 fields · synced Jul 29, 2026
- EUDAMED 5fffcb45-c4c2-4841-8881-e1cc6d85007f 61 fields · synced Jul 29, 2026