FDA.reportPublic FDA data

VADI

Primary DI
04719894380919
Brand
VADI
Company
VADI MEDICAL TECHNOLOGY CO., LTD.
Model
900150L
Catalog number
900150L-CFS
Device description
Respiratory humidifier---Accessories- Heated wire (with port)
Published
2023-10-16
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
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
04719894380919PackageGS110In Commercial Distribution
14719894380909PackageGS1120In Commercial Distribution
04719894380902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719894380919047198943809194719894380919
1471989438090914719894380909
04719894380902047198943809024719894380902

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory gas heating wire, adultA non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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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