IRRIGATOR/INSUFFLATOR

GUDID 04961333242962

YOKE ADAPTER, EGA-501P

PENTAX OF AMERICA, INC.

Gastrointestinal endoscopic insufflator

• Primary Device ID: 04961333242962
• NIH Device Record Key: 73a0586c-47c7-4875-9e8f-29fa9053e764
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRIGATOR/INSUFFLATOR
• Version Model Number: EGA-7012
• Company DUNS: 083211284
• Company Name: PENTAX OF AMERICA, INC.
• Device Count: 1
• 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	04961333242962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113310

FDA Product Code

• FCX: Insufflator, Automatic Carbon-Dioxide For Endoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-12

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