FDA.reportPublic FDA data

Typenex Heat and Moisture Exchanger with Filter

Primary DI
10810050854433
Brand
Typenex Heat and Moisture Exchanger with Filter
Company
TYPENEX MEDICAL LLC
Model
RE0101
Device description
Heat and Moisture Exchanger with Filter (Small)
Published
2022-04-05
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
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
10810050854433PackageGS150In Commercial Distribution
00810050854436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085443310810050854433
00810050854436008100508544368100508544360810050854436

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
312-888-4064mchoquette@typenex.com

Regulatory Flags#

DUNS number
600850213
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
true
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
00810050851954Typenex Introducer SetMS17122020-06-09
00810050853460Typenex Introducer SetMS1235S2021-01-26
00810050853491Typenex Introducer SetMS1335S2021-01-26
00810050853514Typenex Introducer SetMS1835S2021-01-26
00810050853774Typenex Introducer SetMS19122021-08-11
00810050853804Typenex Introducer SetMS21122021-08-11
00810050853811Typenex Introducer SetMS20122021-08-11
00810050853842Typenex Introducer SetMS22122021-08-11
00810050855808Typenex Introducer SetMS2335S2025-11-17
00812269032957Typenex Introducer SetMS02362019-09-18
00812269032971Typenex Introducer SetMS03362019-09-18
00812269032995Typenex Introducer SetMS04362019-09-18
00812269033015Typenex Introducer SetMS05362019-09-18
00812269033039Typenex Introducer SetMS06362019-09-18
00812269033053Typenex Introducer SetMS02442019-09-18
00812269033077Typenex Introducer SetMS03442019-09-18
00812269033091Typenex Introducer SetMS04442019-09-18
00812269033114Typenex Introducer SetMS1144S2019-09-18
00812269033138Typenex Introducer SetMS1244S2019-09-18
00812269033152Typenex Introducer SetMS1344S2019-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530110086Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-27
10885632520341HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520358HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-27
10885632520327HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
10885632520334HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
20885632532129HALYARDOWENS & MINOR DISTRIBUTION, INC.CAH2026-10-21
00848530093686Oxygen, Bacteria & HEPA FilterSunset Healthcare Solutions, Inc.CAH2026-10-19
B462100053363PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
B462100053393PentairPENTAIR FILTRATION SOLUTIONS, LLCCAH2026-08-21
10612479284002McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284026McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284040McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284064McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284101McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
10612479284125McKessonMCKESSON MEDICAL-SURGICAL INC.CAH2026-08-03
14026704927736GIBECKTELEFLEX INCORPORATEDCAH2026-08-01
14026704928993GIBECKTELEFLEX INCORPORATEDCAH2026-07-28
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
00848530089115Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089139Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530089108Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-08-06
00848530093839Cough Assist KitSunset Healthcare Solutions, Inc.CAH2025-05-21
00848530099503Bacteria FilterSunset Healthcare Solutions, Inc.CAH2025-05-15
00848530092283Breathing CircuitSunset Healthcare Solutions, Inc.CAH2025-05-15