| Primary Device ID | 10817984011055 |
| NIH Device Record Key | 1d557e5e-dc81-4cc8-a5e2-c2e0e2a50577 |
| Commercial Distribution Discontinuation | 2020-01-10 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Tube Set |
| Version Model Number | 0600-2203-000 |
| Catalog Number | 0600-2203-000 |
| Company DUNS | 606939072 |
| Company Name | MECTRA LABS, INC. |
| Device Count | 1 |
| 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 | false |
| 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 |
| Phone | +1(800)323-3968 |
| mectrasales@mectralabs.com | |
| Phone | +1(800)323-3968 |
| mectrasales@mectralabs.com |
| Handling Environment Temperature | Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit |
| Handling Environment Temperature | Between 20 Degrees Fahrenheit and 115 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817984011058 [Primary] |
| GS1 | 10817984011055 [Package] Contains: 00817984011058 Package: Inner pack [10 Units] Discontinued: 2020-01-10 Not in Commercial Distribution |
| GBX | CATHETER, IRRIGATION |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-01-13 |
| Device Publish Date | 2019-01-29 |
| 10817984011086 | High Flow Irrigation |
| 10817984011055 | Sinus Vacu-Irrigator |
| 10817984011024 | Double Bottle |
| 10817984011017 | Lap Vac-Irrigator |
| 10817984011000 | Dual Spike |
| 10817984010997 | Pump & Vacuum |
| 10817984010348 | Tube Set Bifurcated Single Spike |
| 10817984010355 | Tube Set Bifurcated Dual Spike |