| Primary Device ID | 20862630000324 |
| NIH Device Record Key | 988c3c70-2f09-43b0-a60c-0d367553633c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VIA-GUARD® |
| Version Model Number | SMK 300 |
| Catalog Number | SMK 300 |
| 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 | 00862630000320 [Primary] |
| GS1 | 10862630000327 [Package] Contains: 00862630000320 Package: Inner Pack [10 Units] In Commercial Distribution |
| GS1 | 20862630000324 [Package] Contains: 10862630000327 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 | 2018-04-12 |
| 20862630000331 | Standard Yankauer Via-Guard® Suction Set |
| 20862630000324 | Classic Via-Guard® Suction Set |
| 00862630000306 | Standard Yankauer Via-Guard® Suction Set |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VIA-GUARD 73688951 1490047 Live/Registered |
SURGIMARK, INC. 1987-10-13 |