FDA.reportPublic FDA data

VIROBAC II®

Primary DI
00612649215426
Brand
VIROBAC II®
Company
King Systems Corporation
Model
20802
Catalog number
20802
Device description
VII VIRAL/BACTERIAL EXHALATION FILTER
Published
2021-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAHFilter, bacterial, breathing-circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K880681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K880681000MINI-FILTER, VIROBAC IIKing Systems Corp.1988-04-29CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612649215419PackageGS150In Commercial Distribution
00612649215426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612649215419006126492154196126492154190612649215419
00612649215426006126492154266126492154260612649215426

GMDN Terms#

Term, Definition table
TermDefinition
Microbial medical gas filter, single-useA screening device intended to remove microbes from medical gases to prevent patient exposure during respiration, anaesthesia and/or endoscopy; it has no additional non-filtering functions. It is a small plastic housing containing a filter which will typically also filter other particulates (e.g., scale). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
009299017
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612649196398ADULT ANESTHESIABREATHING CIRCUIT8403F-80Z8403F-80Z2016-09-22
00612649198552ADULT ANESTHESIA8600B-848600B-842020-10-21
00612649198651ADULT ANESTHESIABREATHING CIRCUIT8603F-6121Z8603F-6121Z2016-09-22
00612649198668ADULT ANESTHESIABREATHING CIRCUIT8603F-61Z8603F-61Z2016-09-22
00612649200033UNIVERSAL F2®C0120-230C0120-2302022-12-13
00612649200071UNIVERSAL F2®C060-230C060-2302023-01-16
00612649200118UNIVERSAL F2®C090-230C090-2302022-12-13
00612649200125UNIVERSAL F2®C090-61C090-612022-12-13
00612649200149UNIVERSAL F2®C360-61ZC360-61Z2022-12-13
00612649200323ADULT ANESTHESIABREATHING CIRCUITCP-01084CP-010842016-09-22
00612649200934UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD360-808ZD360-808Z2016-09-22
00612649201078UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD366-618ZD366-618Z2016-09-22
00612649201214UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-16421ZD395-16421Z2016-09-22
00612649201238UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD395-8021ZD395-8021Z2016-09-22
00612649201283UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-6121ZD440-6121Z2016-09-22
00612649201306UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD440-80ZD440-80Z2016-09-22
00612649201337UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD445-80ZD445-80Z2016-09-22
00612649201597UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465-80ZD465-80Z2016-09-22
00612649201610UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD465V-8021ZD465V-8021Z2016-09-22
00612649201627UNIVERSAL F2®ANESTHESIA BREATHING CIRCUITD466-6121ZD466-6121Z2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08697645018150ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018167ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018174ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
08697645018181ENDURE INDUSTRIESENDURE INDUSTRIESCAH2026-04-17
10197344157938MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
10197344157945MEDLINEMEDLINE INDUSTRIES, INC.CAH2025-09-12
07640142190882EasyOne Filter SPNDD Medizintechnik AGCAH2022-12-09
07640142190899EasyOne Filter FTNDD Medizintechnik AGCAH2022-12-09
10193489339826Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAH2022-08-04
10193489139990MedlineMEDLINE INDUSTRIES, INC.CAH2022-08-03
09420012432339Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAH2022-08-02
10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
10193489019452HYDRO-GUARD MINI BREATHING FILTER Intersurgical IncorporatedCAH2021-10-05
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09
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10190752135987Vital Signs™AirLife Finland OyCAH2021-03-05
10190752135994Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136632Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136793Vital Signs™AirLife Finland OyCAH2021-03-05
10190752136809Vital Signs™AirLife Finland OyCAH2021-03-05
10190752138094Vital Signs™VYAIRE MEDICAL, INC.CAH2021-03-05
10190752139107Vital Signs™AirLife Finland OyCAH2021-03-05
10190752139558Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140080Vital Signs™AirLife Finland OyCAH2021-03-05
10190752140097AirLife™AirLife Finland OyCAH2021-03-05
10190752136724Vital SignsAirLife Finland OyCAH2021-03-01
10190752147171AirLife™AIRLIFECAH2020-02-04
10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04