FDA.reportPublic FDA data

BVF22 Bacteria Filter

Primary DI
00819989014904
Brand
BVF22 Bacteria Filter
Company
EXCELERON MEDICAL, INC.
Model
BVF22
Device description
BVF22 Bacteria Filter
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K851070000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K851070000RESP-BAC BACTERIA FILTERMedicomp, Inc.1985-06-14CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819989014904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819989014904008199890149048199890149040819989014904

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial filter, non-sterileA non-sterile device intended to be placed within a breathing circuit proximal to the patient, to remove and retain microbes whilst capturing the patient's exhaled heat and moisture so that they can be used to heat and humidify the therapeutic gases inspired by the patient. It is typically a plastic housing which contains both a bidirectional microbial filter, intended to reduce the risk of cross-contamination between patients, and a heat/moisture exchanger (HME), intended to maintain the mucous membranes of the respiratory tract. It is typically used during anaesthesia or periods of prolonged respiratory support/therapy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
825179992
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819989011576Thermalite Heated CPAP TubeCTUB-06H15DS2025-01-10
00812970012002NuwaveNW-001NW-0012020-09-23
00812970012019NuwaveNW-002NW-0022020-09-23
00812970012026NuwaveNW-003NW-0032020-09-23
00812970012033NuwaveNW-004NW-0042020-09-23
00812970012040NuwaveUSB-PWR-ADPT-ULUSB-PWR-ADPT-UL2020-09-23
00812970012057NuwaveUSB-PWR-CORDUSB-PWR-CORD2020-09-23
00812970012064NuwaveUSB-PWR-ADPT-KITUSB-PWR-ADPT-KIT2020-09-23
00812970012071NuwaveNUWAVE-BG-SMNUWAVE-BG-SM2020-09-23
00812970012088NuwaveNUWAVE-BG-LGNUWAVE-BG-LG2020-09-23
00812970012095NuwaveCO-001CO-0012020-09-23
00812970012101NuwaveCO-001-KTCO-001-KT2020-09-23
00819989011187CPAP TubingCTUB-018-12021-05-24
00819989011002CPAP TubingCTUB-010-12020-09-24
00819989011026CPAP TubingCTUB-06S-12020-09-23
00819989011040CPAP TubingCTUB-060-12020-09-23
00819989011064CPAP TubingCTUB-080-12020-09-23
00819989011088CPAP TubingCTUB-090-12020-09-23
00819989011101CPAP TubingCTUB-100-12020-09-23
00819989011125CPAP TubingCPAP-TUBE-6FT-SPL-12020-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00817081028669PFT Kit J, 31s VBMax Filter with Blue Foam Nose ClipA-M SYSTEMS, LLCCAH2026-06-23
00848530109257Oxygen, Bacteria & HEPA FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-06-23
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
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000Dynarex CorporationCAH2021-04-22
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000Dynarex CorporationCAH2021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500Dynarex CorporationCAH2021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500Dynarex CorporationCAH2021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600Dynarex CorporationCAH2021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) FilterDynarex CorporationCAH2021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500Dynarex CorporationCAH2021-04-22
00840117305861Resp-O2 Advantage Respiratory B/V FilterDynarex CorporationCAH2021-04-22
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex TubeDynarex CorporationCAH2021-04-22
10190752141834AirLife™VYAIRE MEDICAL, INC.CAH2021-04-09