FDA.reportPublic FDA data

Aero-T+

Primary DI
00841470103743
Brand
Aero-T+
Company
ENGINEERED MEDICAL SYSTEMS INC
Model
301-401
Published
2023-12-11
Public version status
New
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
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470103740PackageGS150In Commercial Distribution
00841470103743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010374010841470103740
00841470103743008414701037438414701037430841470103743

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A 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."

Regulatory Flags#

DUNS number
154502934
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470106218ABC -Flex Tube SystemF060323M3X1E42025-04-11
00841470106263ABC - Uniflow Breathing CircuitU060323M1X1E42025-04-11
00841470106287ABC - Duoflow Bi-lumen Breathing CircuitD072323M2X1E42025-04-11
00841470106348ABC - Flex Tube SystemF060323M0X1E52025-04-11
00841470106577ABC - Compact Breathing CircuitC120323M0X1A42025-04-11
00841470106584ABC - Compact Breathing CircuitC120323M0X1E52025-04-11
00841470106737ABC - Duoflow Bi-lumen Breathing CircuitD072323M0X1A42025-04-11
00841470107116ABC - Uniflow Breathing CircuitU072323M0X1A42025-04-11
00841470107659ABC - Uniflow Breathing CircuitU096323M0X1A42025-04-11
00841470108625ABC - Flex Tube SystemF96M317M0X1A42025-04-11
00841470108731ABC - Duoflow Bi-lumen Breathing CircuitD12M317M1X1A42025-04-11
00841470108847ABC - Pediatric Compact Breathing CircuitPC12123M900002025-04-11
00841470108946ABC - Duoflow Bi-lumen Breathing CircuitD72M317M1X1A42025-04-11
00841470108953ABC - Pediatric Compact Breathing CircuitPC12113M0X5002025-04-11
00841470109455ABC - Compact Breathing CircuitC120323M0X1C52025-04-11
00841470109486ABC - Compact Breathing CircuitC072323M1X1A42025-04-11
00841470109493ABC - Compact Breathing CircuitC120323M1X1E52025-04-11
00841470109509ABC - Duoflow Bi-lumen Breathing CircuitD120323M1X1A42025-04-11
00841470109523ABC - Uniflow Breathing CircuitU072323M0X1002025-04-11
00841470109530ABC - Uniflow Breathing CircuitU072323M0X1E52025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848253002224InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002231InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002248InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002279InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002286InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002309InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002316InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848253002323InHealth Technologies; Blom-SingerFreudenberg Medical, LLCBYD2026-10-06
00848530106430Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2026-08-15
04719874951467Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
04719874955939Create BiotechCREATE BIOTECH CO., LTD.BYD2026-07-16
08904428744916OSSEOUS- ShowerProtectEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904428745067OSSEOUS- TouchFree HME Series - StandardEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
00848530107284Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2025-08-19
14026704927453GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
14026704929723GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
00848530062316Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096922Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096946Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096953Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530103637Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530096908Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-07-31
00848530083274Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
00848530083298Heat Moisture ExchangerSunset Healthcare Solutions, Inc.BYD2024-06-28
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
07331791015854TrachPhone (5 pcs)Atos Medical ABBYD2023-06-19
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791002861TrachPhone (50 pcs)Atos Medical ABBYD2022-11-29
07331791009693TrachPhone (30 pcs)Atos Medical ABBYD2022-11-29