FDA.reportPublic FDA data

Neo-natal HMEF

Primary DI
15060120951967
Brand
Neo-natal HMEF
Company
GVS FILTER TECHNOLOGY UK LTD
Model
9080/100BAUA001/0001
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
25060120951964PackageGS150In Commercial Distribution
35060120951961PackageGS1300In Commercial Distribution
15060120951967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2506012095196425060120951964
3506012095196135060120951961
1506012095196715060120951967

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
769934225
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060120950694Insufflation Set6421/04BPKBTU001/00012026-02-20
25060120950691Insufflation Set6421/04BPKBTU001/00012026-02-20
05060120956415Nose ClipA5082026-02-10
15060120956412Nose ClipA5082026-02-10
15060120950106ECO HMEF4331/01BAUA001/00012016-09-23
15060120950779ECO Maxi Filter4222/701BAUA001/00012016-09-23
15060120951677Spiroguard 2800/21BAUC001/00012016-09-23
15060120952490Multi-vent3000/07DAUA001/00012016-09-23
15060120952520L4 New Intake Filter3200/06AIUA058/00012016-09-23
15060120952537Respironics Domed (Gherkin)3400/01AIUA058/00012016-09-23
15060120952544Tyco-Achieva Bulk3500/01BAUA001/00012016-09-23
15060120952551Inogen3700/02BAUD001/00012016-09-23
15060120952568Maxi-Pleat6888/20BAUA001/00012016-09-23
15060120952575ECO Range4222/02BAUA001/00012016-09-23
15060120952582Standard HME6200/51BAUA069/00012016-09-23
15060120952599Standard HMEF6200/300BAUA069/00012016-09-23
15060120952605High Deadspace Body3888/01BIUA019/00012016-09-23
05060120956293Multi-Vent3000/03DAUA101/00012018-11-30
05060120957740HEPA Ventilation Filter4020/03ABMA001/00012020-06-26
15060120950571Insufflation Filter6421/04BAUA001/00016421/042025-12-11

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