Identity
- Trade Name
- Hytrel Hose, 22F/19T, 60cm, Blue EUDAMEDgalemed FDA UDI
- Generic Name
- Ventilator IMV supplemental circuit, reusable FDA UDI
- Device Name
- Reusable Hytrel Hose EUDAMED
- Model / Reference
- (Q) Tubing EUDAMEDAT0003 EUDAMED38023 FDA UDI
Identifiers
- Catalog Number
- Disposable Humidification Chamber - Auto feeding (IV:120cm) FDA UDI
- Primary DI / UDI-DI
- 04710810087394 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008RNQ299 EUDAMED
- Direct Marketing DI
- 04710810087394 EUDAMED
- FDA Product Code
- BZO FDA UDI
- EMDN Code
- R02010101 BREATHING CIRCUITS, W/O WATER TRAP EUDAMED
- GMDN Term
- Ventilator IMV supplemental circuit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5975 FDA UDI
- Market of Registration
- Netherlands 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ventilator IMV supplemental circuit, reusable
galemed by Galemed Corp. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Galemed Corp.
Sources (2)
- FDA UDI ef33582a-25d3-42fa-93d3-1654a6172248 34 fields · synced Jul 10, 2026
- EUDAMED 76557937-f95a-43cc-83f0-6afbd80881e9 61 fields · synced Jul 10, 2026