| Primary Device ID | 00815198012526 |
| NIH Device Record Key | 3c4dad64-bdc3-4b67-8537-9f4459b2250f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TeleVac2 |
| Version Model Number | 5000194 |
| Company DUNS | 787855907 |
| Company Name | Buffalo Filter |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815198012526 [Primary] |
| GAZ | Tubing, Noninvasive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-10 |
| Device Publish Date | 2016-09-23 |
| 00815198012526 | Start-Up Kit with the following components: Multi-Port ULPA Filter - 00815198012489, Footswitch |
| 00815198012489 | Multi-Port ULPA Filter |