FDA.reportPublic FDA data

Quality Connect HD

Primary DI
04251411703714
Brand
Quality Connect HD
Company
DEHAS Medical Systems GmbH
Model
UI025
Catalog number
HD-CO2-716-W21-1,02
Device description
CO2 high pressure tube 102 cm, Storz insufflator connection 7/16"-20UNF on both sides + mounted ISO adapter with sinter filter. A length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.
Published
2023-01-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
04251411703714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251411703714042514117037144251411703714

GMDN Terms#

Term, Definition table
TermDefinition
High-pressure medical gas hoseA length of flexible tube intended to deliver and withstand gases under very high pressure, e.g., greater than 200 bar/3000 pounds per square inch (psi). It may be composed of any of several malleable or semi-rigid materials (e.g., plastic, rubber, or nylon), and braided with cotton wool and/or stainless steel. It is typically used to transport high pressure compressed medical gas to a pressure regulating device. It is available in various lengths, including standard coil lengths. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+49451809040info@dehas.de

Regulatory Flags#

DUNS number
343728657
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251411703691Quality Connect HDUI024HD-CO2-716-W21-0,552023-01-02
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
04251411706029QualityREGDM-AD-CO2-NIST-DIN-KDM-AD-CO2-NIST-DIN-K2024-07-24
04251411701833Quality Connect DIN-CO2-NIST-NIST-1,5DIN-CO2-NIST-NIST1,52024-04-16
04251411701840Quality ConnectDIN-CO2-ZGV-NIST-1,5DIN-CO2-ZGVNIST1,52024-04-16
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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