FDA.reportPublic FDA data

Anesthesia Circuit Kit

Primary DI
10889483609002
Brand
Anesthesia Circuit Kit
Company
WESTMED, INC.
Model
9806
Device description
"120"" Uni-lim™ coaxial circuit, patient elbow with capped gas sample port, large adult mask, M/M GSL 10' X .050ID X .108OD, 1 B/V filter, disposable"
Published
2023-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAHFilter, Bacterial, Breathing-Circuit
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
OFPAnesthesia Breathing Circuit Kit (Adult & Pediatric)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922492000SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTERSpecialty Packaging Producs, Inc.1992-08-24CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483609006PackageGS120In Commercial Distribution
10889483609002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088948360900630889483609006
1088948360900210889483609002

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Regulatory Flags#

DUNS number
092673953
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00709078003349Mod Kit Pulset™3362-912017-03-30
00709078003356Pulset3363-912017-03-30
00709078003974A-Line3100-302021-01-31
00709078004483Pulset3373-912017-08-31
00709078004612Pulset™ 1cc Syringe31002021-04-28
00709078005107Pulset™3165-912017-09-22
00709078006470Pulset3303-502022-05-31
00709078009082Pulset3173-142020-08-31
00709078011849A-Line3300-242020-09-30
00709078011863A-Line3100-202020-09-30
00709078011900A-Line3300-262020-09-30
00709078012013Pulset36002020-09-30
00709078012037Pulset3600-202020-09-30
00709078013287Atellica® VTR Syringes115613402022-02-28
00709078013300Atellica® VTR Syringes115613412022-02-28
00709078013324Atellica® VTR Syringes115613422022-02-28
00709078013348Atellica® VTR Syringes115613432022-02-28
00709078013362Atellica® VTR Syringes115613442022-02-28
00709078013386Atellica® VTR Syringes115613452022-02-28
00709078013409Atellica® VTR Syringes115613462022-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-06-23
10680651497571HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497588HalyardO&M HALYARD, INC.OFP2026-06-06
10680651497595HalyardO&M HALYARD, INC.OFP2026-06-06
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10889483590591AirLife™AirLife Finland OyCAH2025-04-02
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10190752120105Vital Signs™AIRLIFEOFP2022-09-05
10190752120815Vital Signs™AIRLIFEOFP2022-09-05
10190752141957AirLife™AIRLIFEOFP2022-09-05
10190752142008AirLife™AIRLIFEOFP2022-09-05
10190752142015AirLife™AIRLIFEOFP2022-09-05
10190752142114AirLife™AIRLIFEOFP2022-09-05
10190752148932AirLife™AIRLIFEOFP2022-09-05
10190752148949AirLife™AIRLIFEOFP2022-09-05
10190752155022AirLife™AIRLIFEOFP2022-09-05
10190752155039AirLife™AIRLIFEOFP2022-09-05
10190752114340AirLife™AIRLIFEOFP2022-08-22
10190752114357AirLife™AIRLIFEOFP2022-08-22
10190752119987Vital Signs™AIRLIFEOFP2022-08-22
10190752144514AirLife™AIRLIFEOFP2022-08-22
10190752148918AirLife™AIRLIFEOFP2022-08-22
10190752148925AirLife™AIRLIFEOFP2022-08-22
10190752152915Vital Signs™AIRLIFEOFP2022-08-22
10190752154865AirLife™AIRLIFEOFP2022-08-22