FDA.reportPublic FDA data

ECO Range - Mini Series

Primary DI
35019315082997
Brand
ECO Range - Mini Series
Company
GVS Technology (Suzhou) Co., Ltd.
Model
62.002.0087.9067/710CRSA
Published
2016-09-23
Public version status
Update
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
35019315082997PackageGS150In Commercial Distribution
15019315082993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931508299735019315082997
1501931508299315019315082993

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-useA one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-5 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
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

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
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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