| Primary Device ID | 04961333242955 |
| NIH Device Record Key | e794fa12-a8b3-4617-aaa9-7b2d170863e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IRRIGATOR/INSUFFLATOR |
| Version Model Number | EGA-7011 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 04961333242955 [Primary] |
| FCX | Insufflator, Automatic Carbon-Dioxide For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-12 |
| 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 |