FDA.report

Scavenging Tube 5m (197") + 2 x 30F/22M Connector (038-01-248eaGE)

Primary DI
05055788776925
Brand
Scavenging Tube 5m (197") + 2 x 30F/22M Connector (038-01-248eaGE)
Company
FLEXICARE MEDICAL LIMITED
Model
2105488-006
Device description
Scavenging Tube 5m (197") + 2 x 30F/22M Connector (038-01-248eaGE)
Published
2020-06-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications

CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05055788776925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05055788776925050557887769255055788776925

GMDN Terms

TermDefinition
Anaesthetic gas scavenging evacuation hoseA length of flexible tube intended for the controlled extraction of unwanted anaesthetic gases from an anaesthetic gas scavenging system (AGSS) to prevent polluting the work environment. It has a cross-sectional inner diameter larger than tubing used for low-flow anaesthetic gases for less resistance to facilitate the extraction process. It is colour-coded and used to connect the AGSS and the hospital/institution ducting system. It is made of synthetic polymer material(s) that is reinforced (e.g., with woven polyester) and is available in standard coil lengths. It can be used to evacuate other types of gas/air pollutants (e.g., from bone cement preparation). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
504406273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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