Primary Device ID | 57460691956075 |
NIH Device Record Key | cfa0a823-2163-4d37-a111-0919ea6e55b1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | T005086A |
Version Model Number | T005086A |
Catalog Number | T005086A |
Company DUNS | 134139174 |
Company Name | Edwards Lifesciences LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
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 | true |
OTC Over-The-Counter | false |
Phone | +1(800)822-9637 |
tech_support@edwards.com |
Device Size Text, specify | 0 |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place. |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07460691956070 [Primary] |
GS1 | 57460691956075 [Package] Contains: 07460691956070 Package: Shipper [20 Units] In Commercial Distribution |
DXO | Transducer, Pressure, Catheter Tip |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-08-27 |
Device Publish Date | 2018-07-25 |
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50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS | 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS |
00690103019339 - HEART VALVE ACCESSOR | 2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S |
00690103166989 - HEART VALVE ACCESSOR | 2024-10-28 MITRAL SIZER HANDLE |
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 46 | 2024-10-28 RING HANDLE - EXTENDED 4" |
00690103186437 - FLEXIBLE HANDLE | 2024-10-28 FLEXIBLE HANDLE |
00690103210132 - MITRIS Handle 1140M | 2024-10-28 11400M valve handle |
00690103217773 - Edwards EVOQUE Loading System | 2024-10-11 Edwards EVOQUE Loading System |