FDA.report

22MM FLEXTUBE BREATHING SYSTEM WITH 2L BAG, ELBOW AND LIMB, 1.6M

Primary DI
05030267144044
Brand
22MM FLEXTUBE BREATHING SYSTEM WITH 2L BAG, ELBOW AND LIMB, 1.6M
Company
INTERSURGICAL INCORPORATED
Model
2010000
Device description
22MM FLEXTUBE BREATHING SYSTEM WITH 2L BAG, ELBOW AND LIMB, 1.6M
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

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
05030267144044PackageGS114In Commercial Distribution
05030267059539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05030267144044050302671440445030267144044
05030267059539050302670595395030267059539

GMDN Terms

TermDefinition
Anaesthesia breathing circuit, reusableA non-sterile assembly of devices designed to conduct medical gases from the fresh gas supply outlet of an anaesthesia unit/workstation to the patient typically connecting the patient, a ventilator/ventilation bag, carbon dioxide (CO2) absorber, and a monitor. It typically includes both an inhalation and exhalation route and consists of breathing tubes, a ventilation and/or reservoir bag(s), a Y-piece, connectors/adaptors, and gas sampling ports. The absorber, a one-way directional valve, and adjustable pressure limiting (APL) valve are also devices typically employed in the circuit but may not be a part of this device. It may be conductive or non-conductive. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
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
true
Sterilization required before use
false

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