FDA.reportPublic FDA data

VADI

Primary DI
14719875347020
Brand
VADI
Company
VADI MEDICAL TECHNOLOGY CO., LTD.
Model
VH-210
Catalog number
800-21101-UL
Device description
The Bacteria Filter Heater is designed to warm the patient's exhalation gas as it passes through the main flow bacteria filter on its way to the exhalation system. This helps prevent bacteria in the patients exhalation gas from being vented to the room air, reduces cross-contamination of the exhalation system, and minimizes the amount of condensation in the exhalation system.
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IRQUnit, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRQUnit, Heating, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719875347020PackageGS16In Commercial Distribution
04719875347023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987534702014719875347020
04719875347023047198753470234719875347023

GMDN Terms#

Term, Definition table
TermDefinition
Bottle warmerA mains electricity (AC-powered) heating device into which a bottle is intended to be placed for the preheating of its contents (e.g., milk for feeding infants, water, or other fluids). It typically consists of a tabletop device that has a well(s) for placement of the bottle(s), a heating element, a thermostat, and operating controls. It is designed to be portable for use in different locations.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
657254280
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898966442933IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
07898966442964IbramedIbramed Industria Brasileira de Equipamentos Medicos EirIRQ2025-02-25
00092237626009HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237626016HydraThermDrive Devilbiss HealthcareIRQ2024-05-14
00092237625545HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625552HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625569HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625576HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625583HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625590HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625606HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625613HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625620HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625637HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625644HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625651HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625668HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625675HydraThermDrive Devilbiss HealthcareIRQ2024-03-06
00092237625460HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625477HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625484HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625491HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625507HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625514HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625521HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625538HydraThermDrive Devilbiss HealthcareIRQ2024-03-05
00092237625439HydraThermDrive Devilbiss HealthcareIRQ2024-03-01
00092237625354HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625361HydraThermDrive Devilbiss HealthcareIRQ2024-02-29
00092237625378HydraThermDrive Devilbiss HealthcareIRQ2024-02-29