FDA.reportPublic FDA data

N/A

Primary DI
04961333243419
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
KUMOF-B58K
Device description
SUCTION VALVE, 2 PCS
Published
2018-03-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914008000PENTAX CYSTOFIBERSCOPE, MODEL FCY-15PPentax Precision Instrument Corp.1992-01-10FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333243419PrimaryGS10
14961333243416Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333243419049613332434194961333243419
1496133324341614961333243416

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, reusableA non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""High-level Disinfectant""]"
Ethylene Oxide;High-level Disinfectant

Regulatory Flags#

DUNS number
083211284
Device count
2
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28