| Primary Device ID | 10073796634008 |
| NIH Device Record Key | eeef88e3-4959-40a6-942f-2be43dd71a93 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omron Pocket Pain Pro |
| Version Model Number | PM400 |
| Catalog Number | PM400 |
| Company DUNS | 054318779 |
| Company Name | Omron Healthcare, 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 | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-634-4350 |
| ohiquality@omron.com |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00073796634001 [Primary] |
| GS1 | 10073796634008 [Package] Contains: 00073796634001 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 50073796634006 [Package] Contains: 00073796634001 Package: Inner Carton [4 Units] In Commercial Distribution |
| NYN | Stimulator, Electrical, Transcutaneous, For Arthritis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2019-03-31 |
| 00073796630294 | Electrotherapy Pocket Pain Pro TENS Unit |
| 10073796634008 | TENS Therapy Pain Relief device that relieves Chronic, Acute and Arthritic Pain - 5 Preset modes |