FDA.reportPublic FDA data

Disposable Anesthesia Circuits

Primary DI
10709078010184
Brand
Disposable Anesthesia Circuits
Company
WESTMED, INC.
Model
8026
Device description
Adult Unheated Respiratory Circuit, 72"
Published
2020-09-30
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

Product Codes#

Code, Name table
CodeName
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAICircuit, Breathing (W Connector, Adaptor, Y Piece)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10709078010184PackageGS120In Commercial Distribution
00709078010187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907801018410709078010184
00709078010187007090780101877090780101870709078010187

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078000515Nebulizer02232016-11-24
00709078000560Nebulizer03252016-11-24
00709078000614Nebulizer02052016-11-24
00709078006197VixOne Nebulizer02332018-11-30
20889483528614AMBU Hyperinflation System900 000 6142026-03-05
20889483528737AMBU Hyperinflation System900 000 6172026-03-05
20889483528751AMBU Hyperinflation System900 000 6182026-03-05
20889483528867AMBU Hyperinflation System900 000 6242026-03-05
20889483528942AMBU Hyperinflation System900 000 6282026-03-05
20889483568795AMBU Hyperinflation System900 000 6012026-03-05
20889483542801AMBU Hyperinflation System900 000 6022026-03-05
20889483542849AMBU Hyperinflation System900 000 6042026-03-05
20889483542863AMBU Hyperinflation System900 000 6052026-03-05
20889483542887AMBU Hyperinflation System900 000 6062026-03-05
20889483542924AMBU Hyperinflation System900 000 6092026-03-05
20889483542962AMBU Hyperinflation System900 000 6112026-03-05
10709078000574VixOneVOID 02482025-11-24
00709078049996FilterVoid OU812b2025-09-23
00709078050008FilterVoid OU812a2025-09-23
10709078008402Flex Extenders7-51322024-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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44710810087682N/AGALEMED CORPORATIONCAI2026-03-05
44710810088559N/AGALEMED CORPORATIONCAI2026-03-05
44710810101319N/AGALEMED CORPORATIONCAI2026-03-05
44710810103504N/AGALEMED CORPORATIONCAI2026-03-05
44710810105720N/AGALEMED CORPORATIONCAI2026-03-05
44710810105737N/AGALEMED CORPORATIONCAI2026-03-05
44710810110915N/AGALEMED CORPORATIONCAI2026-03-05
44710810116108N/AGALEMED CORPORATIONCAI2026-03-05
44710810080867N/AGALEMED CORPORATIONCAI2026-03-04
44710810087859N/AGALEMED CORPORATIONCAI2026-03-04
44710810088474N/AGALEMED CORPORATIONCAI2026-03-04
44710810089808N/AGALEMED CORPORATIONCAI2026-03-04
44710810103146N/AGALEMED CORPORATIONCAI2026-03-04
44710810114098N/AGALEMED CORPORATIONCAI2026-03-04
44710810116092N/AGALEMED CORPORATIONCAI2026-03-04
44710810116924N/AGALEMED CORPORATIONCAI2026-03-04
20889483300135Respan®SUNMED, LLCCAI2026-02-11
46923980110359N/AGaleMed Xiamen Co., Ltd.CAI2026-02-05
M368H0678972HAUSTEDGF HEALTH PRODUCTS, INC.CAI2025-10-31
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