| Primary Device ID | 14543527251959 | 
| NIH Device Record Key | 78d8eb3e-5d6c-4d88-87f6-a2a977ba0e8f | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Super Sheath CBDE | 
| Version Model Number | (CBDE) CI12L25TP0038 | 
| Company DUNS | 690724240 | 
| Company Name | TOGO MEDIKIT CO.,LTD. | 
| 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 | 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 | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature, in a dry, dark place. | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04543527251952 [Primary] | 
| GS1 | 14543527251959 [Package] Contains: 04543527251952 Package: Box [10 Units] In Commercial Distribution  | 
| GBW | CATHETER, PERITONEAL | 
| Steralize Prior To Use | false | 
| Device Is Sterile | true | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2021-05-24 | 
| Device Publish Date | 2021-05-14 | 
| 14543527266892 - Super Sheath XL | 2025-03-21 | 
| 14543527266908 - Super Sheath XL | 2025-03-21 | 
| 14543527266915 - Super Sheath XL | 2025-03-21 | 
| 14543527266922 - Super Sheath XL | 2025-03-21 | 
| 14543527266939 - Super Sheath XL | 2025-03-21 | 
| 14543527266946 - Super Sheath XL | 2025-03-21 | 
| 14543527266953 - Super Sheath XL | 2025-03-21 | 
| 14543527266960 - Super Sheath XL | 2025-03-21 |