FDA.reportPublic FDA data

Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500

Primary DI
00840117305274
Brand
Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500
Company
Dynarex Corporation
Model
30101
Device description
CO 2 Port, Flex Tube, Adult
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117305281PackageGS130In Commercial Distribution
00840117305274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117305281008401173052818401173052810840117305281
00840117305274008401173052748401173052740840117305274

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger/microbial medical gas filterA 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.

Regulatory Flags#

DUNS number
008124539
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600301072021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) Filter301122021-04-22
00840117305410Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult302012021-04-22
00840117305434Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port302032021-04-22
00840117305458Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube302042021-04-22
00840117305472Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric302052021-04-22
00840117305496Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME) 50302102021-04-22
00840117305557Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303022021-04-22
00840117305885Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port303092021-04-22
00840117312340Resp-O2 Tracheostomy Drain Sponges, Non-woven,4"x4", 6-Ply350502022-05-02
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube302022021-04-22
00840117318113Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303032021-04-22
00840117318137Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303052021-04-22
00840117305519Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303002022-05-10
00840117305533Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303012022-05-10
00840117313545Resp-O2 Disposable Suction Canisters, 800 cc, Float Valve Shutoff, Locking Lid322012022-04-28
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301032021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex TubeDynarex CorporationCAH2021-04-22
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