| Primary Device ID | 64710810117598 |
| NIH Device Record Key | 1569064d-780c-4b09-925e-587d5ecd5e9b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sil.Flex |
| Version Model Number | DP00 |
| Catalog Number | TC Pad 5 mm |
| Company DUNS | 656854379 |
| Company Name | GALEMED CORPORATION |
| Device Count | 10 |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 24710810117590 [Primary] |
| GS1 | 64710810117598 [Package] Contains: 24710810117590 Package: Carton [16 Units] In Commercial Distribution |
| GS1 | 94710810117599 [Unit of Use] |
| CBH | Device, Fixation, Tracheal Tube |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-15 |
| 04710810105265 - Babi.Plus | 2020-05-04 |
| 04710810093579 - Babi.Plus | 2020-05-04 |
| 04710810105258 - JITTO | 2020-04-21 |
| 04710810119897 - JITTO | 2020-04-21 |
| 44710810119895 - JITTO | 2019-03-26 |
| 44710810084476 - N/A | 2018-08-23 |
| 44710810085336 - N/A | 2018-08-23 |
| 44710810080386 - N/A | 2018-07-06 |