FDA.reportPublic FDA data

9080/M/710BRSA

Primary DI
10884389120385
Brand
9080/M/710BRSA
Company
GVS Technology (Suzhou) Co., Ltd.
Model
DYNJAPHME21
Device description
62.002.0109.9080/M/710BRSA
Published
2016-09-23
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
40884389120386PackageGS150In Commercial Distribution
10884389120385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438912038640884389120386
1088438912038510884389120385

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A 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

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
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
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
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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
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10193489085600MedlineMEDLINE INDUSTRIES, INC.CAH2022-07-12
10193489025019MedlineMEDLINE INDUSTRIES, INC.CAH2022-06-10
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10190752140097AirLife™AirLife Finland OyCAH2021-03-05
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10190752147188AirLife™VYAIRE MEDICAL, INC.CAH2020-02-04