FDA.report

Andorate® Disposable Biopsy Valve

Primary DI
04897106950393
Brand
Andorate® Disposable Biopsy Valve
Company
GA Health Company Limited
Model
GAR018
Published
2020-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ODCEndoscope Channel Accessory

Product Code Classifications

CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14897106950390PackageGS1100In Commercial Distribution
24897106950397PackageGS11000In Commercial Distribution
04897106950393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1489710695039014897106950390
2489710695039724897106950397
04897106950393048971069503934897106950393

GMDN Terms

TermDefinition
Endoscopic biopsy valve, single-useA device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
686908512
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DIBrandModelCatalogPublished
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010492026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010502026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010692026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010702026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve Kit1010952026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit1010962026-03-13
14897106957917andorate® 4-piece valve kit1010662026-03-12
14897106958556andorate® 4-piece valve kit1010462026-03-12
14897106958587andorate® 3-piece Valve Kit1010652026-03-12
14897106958617andorate® 4-piece valve kit1010812026-03-12
14897106958624andorate® 4-piece valve kit1010922026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve Kit1010932026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit1010942026-03-12
14897106957979andorate® 3-piece Valve Kit1010872026-02-27
14897106958532andorate® 3-piece Valve Kit1010042026-02-27
14897106958549andorate® 3-piece Valve Kit1010372026-02-27
14897106957832Champion 3-piece valve kit1010042026-01-21
14897106957849Champion 3-piece valve kit1010372026-01-21
14897106957856Champion 4-piece valve kit1010462026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit1010472026-01-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
14897106957887andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957917andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958556andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958587andorate® 3-piece Valve KitGA Health Company LimitedODC2026-03-12
14897106958617andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958624andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-12
10724995247307NAMEDIVATORS INC.ODC2026-03-02
14897106957979andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106958532andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106958549andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106957832Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957849Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957856Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957900Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957924Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957931Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957962Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957986Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957993Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
00697314195036EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2025-12-05
04953170467325SUCTION VALVE MAJ-1443OLYMPUS MEDICAL SYSTEMS CORP.ODC2025-09-25
04953170467332AIR/WATER VALVE MAJ-1444OLYMPUS MEDICAL SYSTEMS CORP.ODC2025-09-25