| Primary Device ID | 74543527243116 |
| NIH Device Record Key | 3ff854be-f6e8-4233-8459-361e33d1a43b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Supercath 5 |
| Version Model Number | SP120-20-25T |
| Company DUNS | 690724240 |
| Company Name | TOGO MEDIKIT CO.,LTD. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543527243117 [Primary] |
| GS1 | 14543527243114 [Package] Contains: 04543527243117 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 74543527243116 [Package] Contains: 14543527243114 Package: Carton [20 Units] In Commercial Distribution |
| FOZ | Catheter, intravascular, therapeutic, short-term less than 30 days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-24 |