FDA.reportPublic FDA data

NA

Primary DI
06938119331071
Brand
NA
Company
Henan Tuoren Medical Device Co.,Ltd.
Model
Infant
Published
2022-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
16938119331085PackageGS1200In Commercial Distribution
26938119331099PackageGS12In Commercial Distribution
06938119331071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693811933108516938119331085
2693811933109926938119331099
06938119331071069381193310716938119331071

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A 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."

Regulatory Flags#

DUNS number
526982680
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06938119329429NABending edge:0#2022-11-18
06938119329450NABending edge:1#2022-11-18
06938119329481NABending edge:2#2022-11-18
06938119329511NABending edge:3#2022-11-18
06938119329542NABending edge:4#2022-11-18
06938119329573NABending edge:5#2022-11-18
06938119329603NA Detachable model:3#2022-11-18
06938119329634NA Detachable model:4#2022-11-18
06938119329665NA Detachable model:5#2022-11-18
06938119331101NATracheotomy 2022-11-18
06938119359020NAMedical Laryngeal Mask Airway(Normal model:1.0# )2022-11-19
06938119359051NAMedical Laryngeal Mask Airway(Normal model:1.5# )2022-11-19
06938119359099NAMedical Laryngeal Mask Airway(Normal model:2.0# )2022-11-19
06938119359136NAMedical Laryngeal Mask Airway(Normal model:2.5# )2022-11-19
06938119359174NAMedical Laryngeal Mask Airway(Normal model:3.0# )2022-11-19
06938119359211NAMedical Laryngeal Mask Airway(Normal model:4.0# )2022-11-19
06938119359259NAMedical Laryngeal Mask Airway(Normal model:5.0# )2022-11-19
06938119359860NABlockbuster Laryngeal Mask Airway(model:1.0# )2022-11-19
06938119359907NABlockbuster Laryngeal Mask Airway(model:1.5# )2022-11-19
06938119359945NABlockbuster Laryngeal Mask Airway(model:2.0#)2022-11-19

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Primary DI, Brand, Company table
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08904461000499OSSEOUS-Heat Moisture Exchanger-AirEON MEDITECH PRIVATE LIMITEDBYD2026-03-13
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10840330700181ProcureTwin Med, LLCBYD2022-11-02
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