| Primary Device ID | 00627843670940 |
| NIH Device Record Key | f52e7397-6644-4202-98dc-7658fac9c7a9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Distender II Barostat |
| Version Model Number | PPS-9.8 |
| Company DUNS | 203222252 |
| Company Name | G&J Electronics 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627843670940 [Primary] |
| FFX | System, Gastrointestinal Motility (Electrical) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-14 |
| 00627843670957 | Protocol Plus Software version 10.3 |
| 00627843670940 | Protocol Plus Version 9.8 software |
| 00627843670933 | Keypad |
| 00627843670926 | Deluxe Perception Panel |
| 00627843670919 | Perception Panel |
| 00627843670902 | External Reservoir Unit 120 mL |
| 00627843670896 | External Reservoir Unit 1300/120 mL |
| 00627843670889 | External Reservoir Unit 1300 mL |