| Primary Device ID | 00852598007196 |
| NIH Device Record Key | 2841e8c0-e4f6-459a-9012-8dd6e5a0f9ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kaiser Touch II |
| Version Model Number | External Penile Rigidity Device |
| Company DUNS | 052255606 |
| Company Name | AUGUSTA MEDICAL SYSTEMS, L.L.C. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | true |
| Phone | 800-827-8382 |
| somatherapy@augustams.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852598007196 [Primary] |
| LKY | Device, External Penile Rigidity |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-07-17 |
| 00852598007004 - Response II | 2018-03-29 Manual vacuum pump |
| 00852598007011 - Soma Therapy OTC | 2018-03-29 Manual Vacuum Pump |
| 00852598007028 - Elite Custom | 2018-03-29 Manual Vacuum Pump |
| 00852598007035 - Somaerect Stf | 2018-03-29 Manual Vacuum Pump |
| 00852598007042 - Touch II | 2018-03-29 Battery Vacuum Pump |
| 00852598007059 - Soma Therapy OTC Plus | 2018-03-29 Battery Vacuum Pump |
| 00852598007066 - Somaerect Stf Plus | 2018-03-29 Battery Vacuum Pump |
| 00852598007073 - Elite Custom Plus | 2018-03-29 Battery Vacuum Pump |