| Primary Device ID | 74543527235326 |
| NIH Device Record Key | 09d52fd2-8d4d-4815-b827-ad427bb20697 |
| Commercial Distribution Discontinuation | 2018-01-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Supercath 5 |
| Version Model Number | SP213-01 |
| Company DUNS | 690724240 |
| Company Name | TOGO MEDIKIT CO.,LTD. |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry, dark, room-temperature cabinet or closet. |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04543527235327 [Primary] |
| GS1 | 14543527235324 [Package] Contains: 04543527235327 Package: Box [50 Units] Discontinued: 2017-02-22 Not in Commercial Distribution |
| GS1 | 74543527235326 [Package] Contains: 14543527235324 Package: Carton [20 Units] Discontinued: 2017-02-22 Not 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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-16 |