| Primary Device ID | 07613117010430 |
| NIH Device Record Key | 996d9bdb-434c-49a4-9ef5-d8fe20f08c68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Soft-Release-O |
| Version Model Number | S10091 |
| Catalog Number | S10091 |
| Company DUNS | 481742760 |
| Company Name | Ypsomed AG |
| Device Count | 10 |
| 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 | true |
| 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 |
| Phone | +1(866)747-6645 |
| support@sooilusa.com |
| Length | 9 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613117010423 [Primary] |
| GS1 | 07613117010430 [Package] Contains: 07613117010423 Package: SHIPPER BOX [10 Units] In Commercial Distribution |
| GS1 | 07613117017415 [Unit of Use] |
| FMF | Syringe, piston |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |
| 07613117010539 | Soft-Release-O Infusion Set, 6 mm soft cannula, 80 cm (31") blue tubing. Infusion set with a sof |
| 07613117010515 | Soft-Release-O Infusion Set, 9 mm soft cannula, 60 cm (24") blue tubing. Infusion set with a sof |
| 07613117010492 | Soft-Release-O Infusion Set, 6 mm soft cannula, 60 cm (24") blue tubing. Infusion set with a sof |
| 07613117010478 | Soft-Release-O Infusion Set, 9 mm soft cannula, 80 cm (31") blue tubing. Infusion set with a sof |
| 07613117010454 | Soft-Release-O Infusion Set, 6 mm soft cannula, 100 cm (39") blue tubing. Infusion set with a so |
| 07613117010430 | Soft-Release-O Infusion Set, 9 mm soft cannula, 100 cm (39") blue tubing. Infusion set with a so |
| 07613117010416 | Soft-Release-O Infusion Set, 9 mm soft cannula, 30 cm (12") blue tubing. / Infusion set with a s |
| 07613117010393 | Soft-Release-O Infusion Set, 6 mm soft cannula, 30 cm (12") blue tubing. / Infusion set with a s |