IRRIGATOR/INSUFFLATOR

GUDID 04961333241781

CO2 TUBING, EGA-501P, 10/PKG

PENTAX OF AMERICA, INC.

Gastrointestinal endoscopic insufflator

• Primary Device ID: 04961333241781
• NIH Device Record Key: a9d4e59a-d2c2-4773-b619-257d9231e926
• Commercial Distribution Discontinuation: 2018-06-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: IRRIGATOR/INSUFFLATOR
• Version Model Number: 100551P
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04961333241781 [Primary]
GS1	14961333241788 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093665

FDA Product Code

• FAJ: Cystoscope And Accessories, Flexible/Rigid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-08
• Device Publish Date: 2018-03-13

On-Brand Devices [IRRIGATOR/INSUFFLATOR]

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