FDA.reportPublic FDA data

McKesson

Primary DI
00612479242883
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-HME001
Device description
FILTER, HME TRACH VENT
Published
2019-04-19
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

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
00612479242883PrimaryGS10
00612479242876Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479242883006124792428836124792428830612479242883
00612479242876006124792428766124792428760612479242876

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

Regulatory Flags#

DUNS number
023904428
Device count
50
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
false
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
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

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
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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, 6 PackFreudenberg Medical, LLCBYD2025-04-01