| Primary Device ID | 00862630000313 |
| NIH Device Record Key | 10259c46-0377-42bf-94cd-ebb915b04cf2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Via‐Guard® |
| Version Model Number | SMK 200 |
| Catalog Number | SMK 200 |
| Company DUNS | 556486553 |
| Company Name | SURGIMARK INC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862630000313 [Primary] |
| GS1 | 10862630000310 [Package] Package: Inner Pack [10 Units] In Commercial Distribution |
| GS1 | 20862630000317 [Package] Contains: 10862630000310 Package: Case [10 Units] In Commercial Distribution |
| JOL | Catheter And Tip, Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2018-03-01 |
| 00862630000306 - Via-Guard® | 2019-02-21 Standard Yankauer Via-Guard® Suction Set |
| 00862630000313 - Via‐Guard® | 2019-02-21Via-Guard® Vascular Suction Set |
| 00862630000313 - Via‐Guard® | 2019-02-21 Via-Guard® Vascular Suction Set |
| 20862630000324 - VIA-GUARD® | 2019-02-21 Classic Via-Guard® Suction Set |
| 20862630000331 - Via-Guard® | 2019-02-21 Standard Yankauer Via-Guard® Suction Set |