FDA.reportPublic FDA data

Typenex Heat and Moisture Exchanger

Primary DI
10810050854464
Brand
Typenex Heat and Moisture Exchanger
Company
TYPENEX MEDICAL LLC
Model
RE0202
Device description
Heat and Moisture Exchanger (Large)
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
BYDCondenser, Heat And Moisture (Artificial Nose)
CAHFilter, Bacterial, Breathing-Circuit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810050854464PackageGS150In Commercial Distribution
00810050854467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081005085446410810050854464
00810050854467008100508544678100508544670810050854467

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
312-888-4064mchoquette@typenex.com

Regulatory Flags#

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
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
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050855815ThermoFlo®60612026-01-26
10810050855805Typenex Introducer SetMS2335S2025-11-17
10810050855782Fibernex Laser SystemLS02012025-07-28
20810050855772Microscope SlidesLC0104B2025-07-14
20810050855765Microscope SlidesPS0204W2025-07-08
20810050855741Microscope SlidesPS0404WXT2025-06-17
20810050855758Microscope SlidesPS0404YXT2025-06-17
00810050855457Rad ControlRT03022025-05-23
00810050855471Rad ControlRT03012025-05-23
20810050855697Microscope SldiesLC01012025-02-03
20810050855703Microscope SlidesLC02032025-02-03
20810050855710Microscope SlidesLC01042025-02-03
20810050855727Microscope Slides LC01032025-02-03
20810050855734Microscope SlidesPS0202WXL2025-02-03
20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
10810050855669ThermoFlo®60012024-11-20
20810050855673Microscope SlidesPS0201WXL2024-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06950743609432Breathing Circuit Bacterial/Viral FilterShaoxing Haitech Medical Products Co., LtdCAH2026-05-23
08904428798421OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428798292OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08906039318012OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
44710810101913N/AGALEMED CORPORATIONBYD2026-03-04
04710810101939N/AGALEMED CORPORATIONBYD2026-03-04
04716770701127HME W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770701158Angled HME with luer lock portBESMED HEALTH BUSINESS CORP.CAH2026-02-11
04716770702230Bacterial Filter (Dead space 32ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703029HMEF W/Luer lock port (Dead space 45ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703036HMEF W/Luer lock port (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
14716770703067HMEF (Dead space 60ml)BESMED HEALTH BUSINESS CORP.CAH2026-02-11
00810050855815ThermoFlo®TYPENEX MEDICAL LLCBYD2026-01-26
30889483228108Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228115Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228122Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228139Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228146Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228153Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228160Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228177Cardinal HealthSUNMED, LLCCAH2025-12-31
30889483228207Cardinal HealthSUNMED, LLCCAH2025-12-31
20889483229740BlockAide™SUNMED, LLCCAH2025-12-31
20889483231675Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233198Vital Signs™SUNMED, LLCCAH2025-12-31
20889483233891Vital Signs™SUNMED, LLCCAH2025-12-31
20889483231750PRO-NOX™SUNMED, LLCCAH2025-12-30
20889483232306Vital Signs™SUNMED, LLCCAH2025-12-30
20889483232849Vital Signs™SUNMED, LLCCAH2025-12-30
20889483233389Vital Signs™SUNMED, LLCCAH2025-12-30