FDA.reportPublic FDA data

FUJIFILM medwork

Primary DI
04044503035158
Brand
FUJIFILM medwork
Company
FUJIFILM medwork GmbH
Model
FROG VAL1-F1-100
Catalog number
VAL1-F1-100
Published
2022-07-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221264000FROG Forceps Valve (VAL1-F1-100)Fujifilm Medwork GmbH2022-06-01ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04044503035158PrimaryGS10
14044503035155Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04044503035158040445030351584044503035158
1404450303515514044503035155

GMDN Terms#

Term, Definition table
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 features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. 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
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04044503008145FUJIFILM medworkPUC1-A1-18-220-1PUC1-A1-18-220-12026-03-31
04044503002341FUJIFILM medworkVAL1-G7-4-50-1VAL1-G7-4-50-12024-07-31
14044503002348FUJIFILM 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