| Primary Device ID | 00810032660291 |
| NIH Device Record Key | 703ed4cb-2e56-4c73-9658-888899012cb1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Zyris, Isovac |
| Version Model Number | EIV0101 |
| Catalog Number | EIV0101 |
| Company DUNS | 068038277 |
| Company Name | ZYRIS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com | |
| Phone | +1(800)560-6066 |
| regulatory@zyris.com |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810032660291 [Primary] |
| EBR | UNIT, SUCTION OPERATORY |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
[00810032660291]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
| 00810032660314 | Isovac, EDU, 2-Pack, UCLA |
| 00810032660307 | Isovac, Three Pack |
| 00810032660291 | Isovac, Single |