FDA.reportPublic FDA data

ECO Maxi filter

Primary DI
25060511621780
Brand
ECO Maxi filter
Company
GVS Technology (Suzhou) Co., Ltd.
Model
4222/701BSSA
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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, non-sterile, single-useA non-sterile 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
420798347
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
100801961497804244/M/711BRSA059/0001DYNJAAHMEHEPA2016-09-23
05060511621786ECO Maxi filter4222/701BSSA2019-01-31
400801961497814244/M/711BRSA059/0001DYNJAAHMEHEPA2016-09-23
15060120954784HEPA Filter4244-701 BRSA2016-09-23
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
10889483590591AirLife™AirLife Finland OyCAH2025-04-02
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