| Primary Device ID | 08717775955702 |
| NIH Device Record Key | 67bd77c8-eb2e-47ed-8431-213d5944cb64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEM |
| Version Model Number | HEM |
| Company DUNS | 416277333 |
| Company Name | Medical Measurement Systems B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717775955702 [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 | 2022-11-28 |
| Device Publish Date | 2016-09-23 |
| 08717775955702 - HEM | 2022-11-28 |
| 08717775955702 - HEM | 2022-11-28 |
| 08717775955870 - HEM FS | 2022-11-28 |
| 08720648846007 - Solar GI air-charged 4P, Compact Pole system | 2022-05-16 Solar GI air-charged 4P, Compact Pole system, 115V |
| 08717775953012 - Impedance/pH, 6 imp channels, 1 pH antimony, Adult, 6.4 Fr | 2020-10-19 |
| 08717775953036 - Impedance/pH, 6 imp channels, 2 pH antimony, Gastric+oes pH, Adult | 2020-10-19 Adult, 6.4 Fr |
| 08717775953067 - Impedance/pH, 6 imp channels, 1 pH antimony, Pediatric, 6.4 Fr | 2020-10-19 |
| 08717775953104 - Impedance/pH, 6 imp channels, 1 pH antimony, Infant, 1.5 cm spacing | 2020-10-19 6.4 Fr |
| 08717775954071 - Impedance/pH, 6 imp channels, 1 pH antimony, LES locator | 2020-10-19 Adult, 6.9 Fr |