Primary Device ID | 00690103166354 |
NIH Device Record Key | 3611ef2f-7484-4831-9dce-5be30fdaffd8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EMBOL-X Intra-Aortic Filter with Duraflo Coating |
Version Model Number | EXMMD |
Catalog Number | EXMMD |
Company DUNS | 134139174 |
Company Name | Edwards Lifesciences LLC |
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)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool, dry, dark place until ready for use. |
Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged device in a cool, dry, dark place until ready for use. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00690103166354 [Primary] |
DTM | Filter, blood, cardiopulmonary bypass, arterial line |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-04-09 |
Device Publish Date | 2016-08-31 |
00690103166378 | EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING |
00690103166361 | EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING |
00690103166354 | EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING |
00690103166347 | EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING |
00690103166330 | EMBOL-X INTRA-AORTIC FILTER WITH DURAFLO COATING |