FDA.reportPublic FDA data

Heat Moisture Exchanger and Filter

Primary DI
16959180705506
Brand
Heat Moisture Exchanger and Filter
Company
VR Medical Technology Co., Ltd.
Model
VR004
Published
2019-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
16959180705506PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1695918070550616959180705506

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
420798349
Device count
1
Premarket exempt
true
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
16959180715697VR Medical Technology Co., Ltd.Closed suction System VR0416082024-08-19
16959180720479VR Medical Technology Co., Ltd.Closed suction System VR0416052024-08-19
16959180731987VR Medical Technology Co., Ltd.Closed suction System VR0416062024-08-19
16959180753194VR Medical Technology Co., Ltd.Closed suction System VR0416072024-08-19
16959180705513Heat Moisture Exchanger and FilterVR0232019-08-20
16959180703830Heat and Moisture Exchanger Filter with Gas Sampling PortVR0032016-09-20
16959180703847Heat and Moisture Exchanger Filter with Gas Sampling Port VR0052016-09-20
16959180703854Heat and Moisture Exchanger Filter VR10002016-09-20
16959180703861Heat and Moisture Exchanger Filter with Gas Sampling Port VR0082016-09-20
16959180703878Breathing Filter VR0102016-09-02
16959180703885HEPA Breathing Filter VR0122016-09-20
16959180703892Heat and Moisture Exchanger Filter with Flexible Tube VR0272016-09-20
16959180704677Heat and Moisture Exchanger Filter VR0892018-02-07
16959180703908Adult Flex TubingVR0172018-02-07
16959180703915Pediatric Flex Tubing VR0182018-02-07
16959180703731Closed Suction SystemVR04114US2020-05-06
16959180704219Closed Suction SystemVR04210US2020-05-06
16959180704318Closed Suction SystemVR04810US2020-05-06
16959180704332Closed Suction SystemVR04814US2020-05-06
16959180704417Closed Suction SystemVR041110US2020-05-06

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