FDA.reportPublic FDA data

FUJIFILM medwork

Primary DI
14044503002348
Brand
FUJIFILM medwork
Company
FUJIFILM medwork GmbH
Model
VAL1-G7-4-50-1
Catalog number
VAL1-G7-4-50-1
Published
2024-07-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODCEndoscope Channel Accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14044503002348PackageGS1100In Commercial Distribution
04044503002341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404450300234814044503002348
04044503002341040445030023414044503002341

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope working-channel valve, single-useA device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 385 4666xx@xx.xx

Regulatory Flags#

DUNS number
330797395
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04044503008145FUJIFILM medworkPUC1-A1-18-220-1PUC1-A1-18-220-12026-03-31
04044503035158FUJIFILM medworkFROG VAL1-F1-100VAL1-F1-1002022-07-07
04044503002341FUJIFILM medworkVAL1-G7-4-50-1VAL1-G7-4-50-12024-07-31
04044503055828FUJIFILM medworkVAL1-G7-50VAL1-G7-502021-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934196EndoSound® Biopsy Port Adapter 5054Endosound, Inc.ODC2026-06-01
00850050934202EndoSound® Biopsy Port Adapter (5 pack) 5064Endosound, Inc.ODC2026-06-01
00724995246693DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246709DEFENDO Disposable Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246716DEFENDO Biopsy Valve IrrigatorMEDIVATORS INC.ODC2026-04-06
00724995246723DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246730DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246747DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246754Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246761Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246778Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246785Defendo Single Use Valve KitMEDIVATORS INC.ODC2026-04-06
00724995246792DEFENDO Valve and Connector KitMEDIVATORS INC.ODC2026-04-06
00724995246808DEFENDO Air/Water/Suction and Biopsy ValveMEDIVATORS INC.ODC2026-04-06
00724995246815DEFENDO Air/Water and Suction ValvesMEDIVATORS INC.ODC2026-04-06
00724995246846DEFENDO SINGLE USE VALVE KITMEDIVATORS INC.ODC2026-04-06
04897106957880andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957897andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957941andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957958andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
04897106957910andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
00724995247300NAMEDIVATORS INC.ODC2026-03-02
04897106957972andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
04897106957835Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957842Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957859Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957866Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957903Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
04897106957927Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
04897106957934Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2026-01-21