FDA.reportPublic FDA data

VADI

Primary DI
04719894380933
Brand
VADI
Company
VADI MEDICAL TECHNOLOGY CO., LTD.
Model
G-314003
Catalog number
G-314003-CFS
Device description
Reusable humidifier chamber
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BZOSet, Tubing And Support, Ventilator (W Harness)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZOSet, Tubing And Support, Ventilator (W Harness)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719894380930PackageGS140In Commercial Distribution
04719894380933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471989438093014719894380930
04719894380933047198943809334719894380933

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
657254280
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719894389189VADI MEDICALG-311025G-311025-B02222026-01-28
04719894389196VADI MEDICALG-311004-2G-311004-2-B02222026-01-28
04719894389202VADI MEDICAL9014-D9014-D-B02222026-01-28
04719894389165VADI MEDICAL9014-039014-03-B02222026-01-20
14719894389162VADI MEDICAL9014-039014-03-B02222026-01-20
04719894389172VADI MEDICAL9014-019014-01-B02222026-01-20
04719894388656VADI MEDICALG-118000-02025-10-02
04719894386317VADI MEDICAL9014-019014-01-510K12025-08-01
04719894386324VADI MEDICAL9014-049014-04-510K12025-08-01
04719894386331VADI MEDICAL9014-009014-00-510K12025-08-01
04719894386348VADI MEDICAL9014-029014-02-510K12025-08-01
04719894386355VADI MEDICAL9014-039014-03-510K12025-08-01
04719894386362VADI MEDICAL9014-059014-05-510K12025-08-01
04719894386379VADI MEDICAL9014-069014-06-510K12025-08-01
04719894386386VADI MEDICAL9014-079014-07-510K12025-08-01
04719894386393VADI MEDICAL9014-089014-08-510K12025-08-01
14719894386314VADI MEDICAL9014-019014-01-510K12025-08-01
14719894386321VADI MEDICAL9014-049014-04-510K12025-08-01
14719894386338VADI MEDICAL9014-009014-00-510K12025-08-01
14719894386345VADI MEDICAL9014-029014-02-510K12025-08-01

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Primary DI, Brand, Company table
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