IRRIGATOR/INSUFFLATOR

GUDID 04961333241781

CO2 TUBING, EGA-501P, 10/PKG

PENTAX OF AMERICA, INC.

Gastrointestinal endoscopic insufflator
Primary Device ID04961333241781
NIH Device Record Keya9d4e59a-d2c2-4773-b619-257d9231e926
Commercial Distribution Discontinuation2018-06-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameIRRIGATOR/INSUFFLATOR
Version Model Number100551P
Company DUNS083211284
Company NamePENTAX OF AMERICA, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104961333241781 [Primary]
GS114961333241788 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FAJCystoscope And Accessories, Flexible/Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-10-08
Device Publish Date2018-03-13

On-Brand Devices [IRRIGATOR/INSUFFLATOR]

04961333242993PUMP HEAD, EGA-500P
04961333242986FOOT PEDAL, EGA-500P
04961333242979POWER CORD, EGA-500P/EGA-501P
04961333242962YOKE ADAPTER, EGA-501P
04961333242955HIGH PRESSURE HOSE 3FT, EGA-501P
04961333242948WATERBOTTLE HOLDER
04961333242931PENTAX MEDICAL CO2 INSUFFLATOR
04961333242924PENTAX MEDICAL IRRIGATION PUMP
04961333241781CO2 TUBING, EGA-501P, 10/PKG
04961333241729IRRIG TUBING, EGA-500P, 10/PKG

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