Resp-O2 Heat Moisture Exchanger (HME) 1000 Tracheostomy Integral Oxygen Port

Primary DI
00840117305519
Brand
Resp-O2 Heat Moisture Exchanger (HME) 1000 Tracheostomy Integral Oxygen Port
Company
Dynarex Corporation
Model
30300
Device description
Adult, Tidal Volume Range(150-1250mL), Media(Foam), Dead Space(16mL), Breathing Resistance(0.2cm H2O at 60L/min), Weight (5.6g)
Published
2022-05-10
Public version status
Update
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
00840117305526PackageGS150In Commercial Distribution
00840117305519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117305526008401173055268401173055260840117305526
00840117305519008401173055198401173055190840117305519

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

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