Identity
- Trade Name
- Quality Connect FDA UDI
- Generic Name
- Carbon dioxide low pressure hose FDA UDI
- Device Name
- Connection Tube DIN, CO2, ZGV connector (without valve) to 7/16"-20UNF fitting, ISO-colored, 6.00 m long A length of reinforced colour-coded flexible tubing produced according to ISO5359 and intended to conduct compressed carbon dioxide (CO2) from a CO2 terminal unit or CO2 cylinder to a medical device that functions with CO2 (e.g., ventilator, insufflation system). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton, and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device. (en) FDA UDI
- Model / Reference
- UI023 FDA UDI
- Description
- Connection Tube DIN, CO2, ZGV connector (without valve) to 7/16"-20UNF fitting, ISO-colored, 6.00 m long A length of reinforced colour-coded flexible tubing produced according to ISO5359 and intended to conduct compressed carbon dioxide (CO2) from a CO2 terminal unit or CO2 cylinder to a medical device that functions with CO2 (e.g., ventilator, insufflation system). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton, and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device. (en) FDA UDI
Identifiers
- Catalog Number
- DIN-CO2-ZGV-716-6,00 FDA UDI
- Primary DI / UDI-DI
- 04251411703806 FDA UDI
- FDA Product Code
- BYX FDA UDI
- GMDN Term
- Carbon dioxide low pressure hose FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5860 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Carbon dioxide low pressure hose
Quality Connect by DEHAS Medical Systems GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DEHAS Medical Systems GmbH
Sources (1)
- FDA UDI 4b959493-8ae9-4376-b34a-4bba1765daf6 36 fields · synced Jun 6, 2026