FDA UDI In Commercial Distribution 🇺🇸 United States

Quality Connect

DI: 04251411703783 · Model: UI022 · DEHAS Medical Systems GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Quality Connect
Primary DI
04251411703783
Version / Model
UI022
Catalog Number
DIN-CO2-ZGV-716-3,00
Company Name
DEHAS Medical Systems GmbH
Labeler DUNS
343728657
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-01-02
Public Version
1
Public Version Date
2023-01-10
Public Version Status
New
Public Device Record Key
dc941aa7-72a0-4070-a7ec-d7a5a891bf46

Device Description

Connection Tube DIN, CO2, ZGV connector (without valve) to 7/16"-20UNF fitting, ISO-colored, 3.00 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)

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
BYX Tubing, Pressure And Accessories

GMDN Terms

Code Name
66374 Carbon dioxide low pressure hose

Identifiers

Type ID
Primary 04251411703783

Customer Contacts

Phone
+49451809040

Storage Conditions

Type
Handling Environment Temperature
Temperature Range
15 – 50 Degrees Celsius
Type
Storage Environment Temperature
Temperature Range
15 – 50 Degrees Celsius