FDA.reportPublic FDA data

VADI MEDICAL

Primary DI
14719894389162
Brand
VADI MEDICAL
Company
VADI MEDICAL TECHNOLOGY CO., LTD.
Model
9014-03
Catalog number
9014-03-B0222
Device description
Ventilator Tubing
Published
2026-01-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

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
14719894389162PackageGS110In Commercial Distribution
04719894389165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471989438916214719894389162
04719894389165047198943891654719894389165

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

Sterilization Methods#

Method table
Method

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
true
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
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
14719894386352VADI MEDICAL9014-039014-03-510K12025-08-01

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