FDA.reportPublic FDA data

HUDSON RCI

Primary DI
04026704348176
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN044418
Catalog number
41312
Published
2018-09-15
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

Contact Domains#

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
24026704348170PackageGS150In Commercial Distribution
44026704348174PackageGS110In Commercial Distribution
04026704348176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670434817024026704348170
4402670434817444026704348174
04026704348176040267043481764026704348176

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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
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
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07331791015564Provox Life Coming Home USAAtos Medical ABBYD2022-11-29
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752105928AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141964AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752141988AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05
10190752139794AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139800AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22
10190752139817AirLife™VYAIRE MEDICAL, INC.BYD2022-08-22