FDA.reportPublic FDA data

Quality Connect

Primary DI
04251411701840
Brand
Quality Connect
Company
DEHAS Medical Systems GmbH
Model
DIN-CO2-ZGV-NIST-1,5
Catalog number
DIN-CO2-ZGVNIST1,5
Device description
Connection hose DIN, CO2, central gas supply plug to NIST-screwing, ISO color, 1.50 m long
Published
2024-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251411701840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251411701840042514117018404251411701840

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide low pressure hoseA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Minus 15° Celsius to +50° Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343728657
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251411706029QualityREGDM-AD-CO2-NIST-DIN-KDM-AD-CO2-NIST-DIN-K2024-07-24
04251411703691Quality Connect HDUI024HD-CO2-716-W21-0,552023-01-02
04251411703714Quality Connect HDUI025HD-CO2-716-W21-1,022023-01-02
04251411703721Quality Connect HDUI026HD-CO2-716-PIN-0,552023-01-02
04251411703745Quality Connect HDUI027HD-CO2-716-PIN-1,022023-01-02
04251411703769Quality Connect HDUI028HD-CO2-716-ISO-1,022023-01-02
04251411703776Quality ConnectUI021DIN-CO2-ZGV-716-1,502023-01-02
04251411703783Quality ConnectUI022DIN-CO2-ZGV-716-3,002023-01-02
04251411703790Quality ConnectUI020DISS-CO2-ZGV-716-1,502023-01-02
04251411703806Quality ConnectUI023DIN-CO2-ZGV-716-6,002023-01-02
04251411701833Quality Connect DIN-CO2-NIST-NIST-1,5DIN-CO2-NIST-NIST1,52024-04-16
04251411703141Quality ConnectNF-CO2-ZGV-NIST-5,0NF-CO2-ZGV-NIST5,02024-04-16
04251411707200Quality ConnectRW-CO2-ZGV-NIST-5,0RW-CO2-ZGV-NIST-5,02024-04-16
04251411705879QualityREGDM-DIN6-MS-NIST-CO22024-04-08
04251411705886QualityREGDM-PIN-MS-NIST-CO2DM-PIN-MS-NIST-CO22024-04-08
04251411705893QualityREGDM-ISO-MS-NIST-CO2DM-ISO-MS-NIST-CO22024-04-08
04251411700010Oxymixer High Flow SETHigh Flow SETMP042012023-02-17
04251411700027Oxymixer Low Flow SETLow Flow SETMP042032023-02-17
04251411700775Oxymixer XL Low FlowXL Low Flow2023-02-17
04251411700928Oxymixer Low Flow 15LPMLow Flow 15LPMMP042292023-02-17

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