FDA.report

72" Anesthesia Breathing Circuit

Primary DI
10709078009737
Brand
72" Anesthesia Breathing Circuit
Company
WESTMED, INC.
Model
9228
Device description
72" Adult Anesthesia Breathing Circuit, Parrallel Wye, Clear GSE, Mini HMEF w/Port, 10' PVC x .050" ID M/M GSL, 3L not made with latex bag, medium adult 900 series mask
Published
2020-08-31
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
true

Related Records

Product Codes

CodeName
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Product Code Classifications

CodeDeviceSpecialtyClass
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078009737PackageGS120In Commercial Distribution
00709078009730PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800973710709078009737
00709078009730007090780097307090780097300709078009730

GMDN Terms

TermDefinition
Anaesthesia breathing circuit, single-useAn 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. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
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
true
Sterilization required before use
false

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20889483542887AMBU Hyperinflation System900 000 6062026-03-05
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Primary DIBrandCompanyProduct codePublished
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0503026716154622mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
0503026716175122mm Compact breathing systemIntersurgical IncorporatedOFP2025-04-14
10889483583388Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587072Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587089Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587096Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587102Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587119Vital Signs™AirLife Finland OyOFP2025-04-14
10889483587126Vital Signs™AirLife Finland OyOFP2025-04-14
10889483590072Vital Signs™AirLife Finland OyOFP2025-04-14
00816472022972Multipac UniFlow anesthesia breathing systemIntersurgical IncorporatedOFP2025-04-11
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10841470108950ABC - Pediatric Compact Breathing CircuitENGINEERED MEDICAL SYSTEMS INCOFP2025-04-11
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