| Primary Device ID | 00681490042109 |
| NIH Device Record Key | e963461e-cf33-4c2c-ac09-ec156dd24982 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Epistat® |
| Version Model Number | 1527031 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 | false |
| Expiration Date | false |
| 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 | 00681490042109 [Primary] |
| EMX | BALLOON, EPISTAXIS |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-13 |
| 00681490042109 | CATHETER 1527031 EPISTAT NASAL |
| 00763000035709 | CATHETER 1527031 EPISTAT NASAL |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPISTAT 76438089 2783891 Live/Registered |
Keltner, Llew 2002-08-06 |
![]() EPISTAT 74448767 not registered Dead/Abandoned |
WARNER-LAMBERT COMPANY 1993-10-18 |
![]() EPISTAT 74207498 not registered Dead/Abandoned |
Keltner, Llew, EPISTAT 1991-09-27 |
![]() EPISTAT 74181367 1750343 Dead/Cancelled |
Keltner, Llew 1991-07-01 |
![]() EPISTAT 73636733 1449500 Live/Registered |
XOMED INC. 1986-12-22 |