FDA.reportPublic FDA data

Disposable anesthesia circuits, Adult 96"

Primary DI
10709078005227
Brand
Disposable anesthesia circuits, Adult 96"
Company
WESTMED, INC.
Model
8973
Device description
Adult 96" GSE, 3L not made with latex, 900 series large adult mask
Published
2017-12-23
Public version status
Update
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
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications

CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10709078005227PackageGS120In Commercial Distribution
00709078005220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1070907800522710709078005227
00709078005220007090780052207090780052200709078005220

GMDN Terms

TermDefinition
Heat/moisture exchanger/microbial filter, non-sterileA non-sterile device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
092673953
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 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 DIBrandCompanyProduct codePublished
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
30889483228108Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228115Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228122Cardinal HealthSUNMED, LLCCAH2025-12-31
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