Hytrel hose 13/13 (N/P) 40
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Hytrelschlauch 13/13 (N/P) 40 EUDAMEDHytrel hose 13/13 (N/P) 40 FDA UDI
- Generic Name
- Ventilator breathing circuit, reusable FDA UDI
- Model / Reference
- 8410816 EUDAMEDFDA UDI208044PK19Z000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675022312 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751208044PK19Z000B8 EUDAMED
- Direct Marketing DI
- 04048675022312 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- Z1203019080 VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Ventilator breathing circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 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
Yes
Manufacturing Date
Yes
Category: Ventilator breathing circuit, reusable
Hytrel hose 13/13 (N/P) 40 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 98b13a15-8aa9-4d9d-962d-305710515b41 33 fields · synced Jun 20, 2026
- EUDAMED e98b0dad-26f8-4acc-8fc5-b73f17914ace 61 fields · synced Jun 20, 2026