Primary Device ID | 00690103216967 |
NIH Device Record Key | 41243957-0169-44c2-9392-85fbe906b3cc |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PASCAL PRECISION |
Version Model Number | 20000GSA |
Catalog Number | 20000GSA |
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 | 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 | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com | |
Phone | +1(800)822-9637 |
tech_support@edwards.com |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00690103216967 [Primary] |
NKM | Mitral Valve Repair Devices |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-09-27 |
Device Publish Date | 2022-09-19 |
50690103000073 - CO-SET INJECTATE ICE BUCKET | 2025-07-24 CO-SET INJECTATE ICE BUCKET 6 PER CASE |
00690103002546 - CLAMP FOR DPT HOLDER | 2025-07-23 PRESSURE MONITORING ACCESSORY |
50690103197902 - TRUCLIP | 2025-07-23 TRUCLIP |
50690103210823 - Combo Kits | 2025-07-23 Pressure Monitoring Set |
00690103216998 - HEMOSPHERE | 2025-07-23 Mindray OEM Pressure Smart Cable |
00690103219111 - Cable | 2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE |
07460691949867 - PRESSURE MONITORING ACCESSORY | 2025-07-23 PRESSURE MONITORING ACCESSORY |
57460691956143 - TruWave | 2025-07-23 PRESSURE MONITORING ACCESSORY |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PASCAL PRECISION 90453770 not registered Live/Pending |
Edwards Lifesciences Corporation 2021-01-07 |