FDA.reportPublic FDA data

ECO Maxi filter

Primary DI
05060511621786
Brand
ECO Maxi filter
Company
GVS Technology (Suzhou) Co., Ltd.
Model
4222/701BSSA
Published
2019-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K033008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033008000AIR SAFETY HEPA AND NON-HEPA FILTERSAir Safety, Ltd.2004-05-13CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15060511621783PackageGS11In Commercial Distribution
25060511621780PackageGS150In Commercial Distribution
05060511621786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1506051162178315060511621783
2506051162178025060511621780
05060511621786050605116217865060511621786

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Regulatory Flags#

DUNS number
420798347
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
100801961497804244/M/711BRSA059/0001DYNJAAHMEHEPA2016-09-23
400801961497814244/M/711BRSA059/0001DYNJAAHMEHEPA2016-09-23
15060120954784HEPA Filter4244-701 BRSA2016-09-23
25060511621780ECO Maxi filter4222/701BSSA2019-01-31
108843891203544333/M/712BRSA059/0001DYNJAAHME52016-09-23
108843891203614333/M/711BRSA059/0001DYNJAAHME12016-09-23
108843891203859080/M/710BRSADYNJAPHME212016-09-23
108843891204089067/M/710BRSA059/0001DYNJAPHME192016-09-23
108843891204229066/M/711BRSA059/0001DYNJAPHME172016-09-23
108843891204469065/M/710BRSA059/0001DYNJAAHME132016-09-23
108843891204609064/M/712BRSA059/0001DYNJAAHME112016-09-23
108843891204849064/M/711BRSA059/0001DYNJAAHME92016-09-23
15019315082979ECO Range - Phase 162.002.0017.8866/100CRSA2016-09-23
15019315082993ECO Range - Mini Series62.002.0087.9067/710CRSA2016-09-23
150193150830379080/750BRSA074/000162.002.0132.9080/750BRSA2016-09-23
15019315083204ECO Maxi Pleat - Pleated HEPA Filter62.002.0095.4244/702CRSA2016-09-23
15019315083211ECO Range - Maxi Series62.002.0070.4333/710CRSA2016-09-23
15019315083297ECO Range - Maxi Series62.002.0079.4244/711CRSA2016-09-23
15019315083303ECO Range - Midi Series62.002.0090.9064/711CRSA2016-09-23
35019315082973ECO Range - Phase 162.002.0017.8866/100CRSA2016-09-23

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
10190752136434Vital Signs™Vyaire GmbHCAH2021-04-02
10190752139589Vital Signs™AirLife Finland OyCAH2021-04-02
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