| Primary Device ID | B989HMI1180 |
| NIH Device Record Key | 94a592b4-1624-4eb3-aa78-288ac670af29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Heidelberg pH Capsule System |
| Version Model Number | Heidelberg Interface Module |
| Catalog Number | HMI118 |
| Company DUNS | 023287700 |
| Company Name | Heidelberg Medical Inc |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com | |
| Phone | 800-241-7517 |
| hdlberg@etcmail.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B989HMI1180 [Primary] |
| FFT | Electrode, Ph, Stomach |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-11-28 |
| Device Publish Date | 2020-11-13 |
| B989HTC1020 | The capsule is a physiologic battery-powered device used for gastric monitoring and data collect |
| B989HMT00180 | The Medallion Transceiver is a battery powered device of the Heidelberg pH Capsule system, desig |
| B989HMI1180 | The interface module is a stationary electronic component of the Heidelberg pH capsule telemetri |