FDA.reportPublic FDA data

DAR

Primary DI
20884521829180
Brand
DAR
Company
Covidien LP
Model
354/5841
Device description
Adult Mechanical Filter HME with Catheter Mount Large
Published
2023-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20884521829180PackageGS125In Commercial Distribution
10884521829183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452182918020884521829180
1088452182918310884521829183

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, Keep dry, This side up

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521091986NellcorSC-A-I2026-05-25
10884521758803Vascufil8886470311V-22020-07-19
10884521816312McGRATH MAC350-005-0002021-10-21
10884521816329McGRATH MAC350-013-0002021-08-30
10884521816336McGRATH MAC350-017-0002021-10-18
10884521816343McGRATH MAC350-072-0002022-06-13
10884521824317McGRATH MAC350-005-0002022-09-25
10884521824324McGRATH MAC350-013-0002021-10-30
10884521824331McGRATH MAC350-017-0002021-08-26
10884521824348McGRATH MAC350-072-0002023-06-19
10884521850118McGRATH MAC350-005-0002025-04-27
10884521850125McGRATH MAC350-013-0002025-04-27
10884521850132McGRATH MAC350-017-0002025-04-27
10884521850149McGRATH MAC350-072-0002025-04-27
15060272980310McGRATH MAC350-005-0002021-08-02
15060272980327McGRATH MAC350-013-0002022-01-17
15060272980334McGRATH MAC350-072-0002021-04-18
15060272980341McGRATH MAC350-017-0002021-03-27
15060272980358McGRATH MAC350-005-0002021-02-27
15060272980365McGRATH MAC350-013-0002021-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00810050855815ThermoFlo®TYPENEX MEDICAL LLCBYD2026-01-26
07331791181153Provox Life Oxygen (10 pcs)Atos Medical ABBYD2025-12-16
07331791181160Provox Life Oxygen (30 pcs)Atos Medical ABBYD2025-12-16
10848530107281Heat Moisture ExchangerSUNSET HEALTHCARE SOLUTIONS, INC.BYD2025-08-19
34026704928935GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928942GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928959GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928966GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928973GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704928980GIBECKTELEFLEX INCORPORATEDBYD2025-08-18
34026704927457GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927467GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704927740GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929010GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929024GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929031GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929492GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929522GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929536GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929720GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
34026704929864GIBECKTELEFLEX INCORPORATEDBYD2025-07-31
24026704929041GIBECKTELEFLEX INCORPORATEDBYD2025-07-30
20884389976064MEDLINEMEDLINE INDUSTRIES, INC.BYD2025-07-16
00848253003948TruFit™ Adhesive Housing, 30 PackFreudenberg Medical, LLCBYD2025-04-01
00848253003931TruFit™ Adhesive Housing, 30 PackFreudenberg Medical, LLCBYD2025-04-01