FDA.reportPublic FDA data

DAR

Primary DI
10884521082502
Brand
DAR
Company
Covidien LP
Model
354/5920
Device description
Adult-Pediatric Mechanical Filter HME with Catheter Mount,Large
Published
2023-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
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
20884521082509PackageGS125In Commercial Distribution
10884521082502PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452108250920884521082509
1088452108250210884521082502

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521620193Shiley18775S2017-04-18
10884521620209Shiley18780S2017-01-06
10884521543805SigniaSIGADAPTSTND2017-08-08
10884521824355McGRATHX3-003-0002021-09-01
10884521032903BiosynGMT-2262015-09-01
10884521073517VersaportNBFCA5ST2016-09-24
10884521085329SofsilkGSJ-36-M2015-09-01
10884521085336SofsilkGSJ-37-M2015-09-01
10884521101999Vascufil88864722-21V2015-08-31
10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
10884521543638Tri-Staple 2.0SIGTRS60AMT2017-05-26
10884521726352ReliaTackRELTACK8RDPTSW2018-06-03
10884523000627SILSSILSHOOK362016-09-24
10884523000917Surgiwand II1780942016-09-24
10884523006599Premium Plus CEEA1119852015-08-28
10884524001500ValleylabE2516HS2016-09-24
10884521195202SonicisionSCD132018-08-10
10884521807884SonicisionSCD132020-06-29
10884521546219LigaSureLIGASUREZD2018-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884389976067MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
10889483571576AirLife™AIRLIFEBYD2025-02-21
10889483571583AirLife™AIRLIFEBYD2025-02-21
10889483571590AirLife™AIRLIFEBYD2025-02-21
10889483571637AirLife™AIRLIFEBYD2025-02-21
10889483334577AirLife™AIRLIFEBYD2025-02-20
10889483571545AirLife™AIRLIFEBYD2025-02-20
10889483571569AirLife™AIRLIFEBYD2025-02-20
10889483571613AirLife™AIRLIFEBYD2025-02-20
10889483571620AirLife™AIRLIFEBYD2025-02-20
10859760005056Passy Muir PASSY-MUIR, INC.BYD2025-02-03
10810050855621ThermoFlo®TYPENEX MEDICAL LLCBYD2024-11-14
10193489024647MedlineMEDLINE INDUSTRIES, INC.BYD2024-03-05
10850014574793HME FlexPEPPER MEDICAL INC.BYD2023-10-25
10884521829060DARCovidien LPBYD2023-09-16
10884521829152DARCovidien LPBYD2023-09-16
10884521829183DARCovidien LPBYD2023-09-16
10884521829190DARCovidien LPBYD2023-09-16
10884521829206DARCovidien LPBYD2023-09-16
10884521829213DARCovidien LPBYD2023-09-16
10884521829220DARCovidien LPBYD2023-09-16
10884521829176DARCovidien LPBYD2023-09-01
10888277702202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BYD2023-01-26
07331791008320HME DigiTop O2Atos Medical ABBYD2022-12-07
07331791015564Provox Life Coming Home USAAtos Medical ABBYD2022-11-29
10840330700181ProcureTwin Med, LLCBYD2022-11-02
10190752105898AirLife™VYAIRE MEDICAL, INC.BYD2022-09-05