FDA.reportPublic FDA data

AVANOS

Primary DI
10609038938216
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
93821
Catalog number
157
Device description
1000 Heat and Moisture Exchange Filter
Published
2020-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K102483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102483000SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104Sunset Healthcare Solutions, LLC2011-09-13CAH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609038938216PackageGS125In Commercial Distribution
00609038938219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060903893821610609038938216
00609038938219006090389382196090389382190609038938219

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags#

DUNS number
079375431
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
00350770009148NeoMed120008812PNM-S35NC2026-07-21
00350770456096CLOG ZAPPER* with Applicator12000154520-00022019-06-21
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
00848530109509Ventilator FilterSUNSET HEALTHCARE SOLUTIONS, INC.CAH2026-07-23
00817081028683PFT KIT F, VBMax 35e Filter KitA-M SYSTEMS, LLCCAH2026-07-17
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