Primary Device ID | 08717648137747 |
NIH Device Record Key | 259fe67a-a587-4a32-8639-42f2f710cc81 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EMBOSHIELD NAV6 |
Version Model Number | 22437-19 |
Catalog Number | 22437-19 |
Company DUNS | 964569052 |
Company Name | ABBOTT VASCULAR 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)227-9902 |
AV.CUSTOMERCARE@AV.ABBOTT.COM |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark area. Do not expose to organic solvents or ionizing radiation. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08717648137747 [Primary] |
NTE | Temporary Carotid Catheter for Embolic Capture |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-04-09 |
Device Publish Date | 2016-02-05 |
08717648137754 | Emboshield NAV6 Embolic Protection System 7.2 mm x 190 cm |
08717648137747 | Emboshield NAV6 Embolic Protection System 5.0 mm x 190 cm |