Primary Device ID | 00690103217957 |
NIH Device Record Key | 16ec05c2-b244-4352-9668-76b3bca97f2f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HemoSphere Alta |
Version Model Number | ALTAALL1 |
Catalog Number | ALTAALL1 |
Company DUNS | 134139174 |
Company Name | Edwards Lifesciences LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
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 | |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00690103217957 [Primary] |
DQE | Catheter, Oximeter, Fiber-Optic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-21 |
Device Publish Date | 2025-03-13 |
00690103217971 | HemoSphere Alta monitor (Cardiac) |
00690103217964 | HemoSphere Alta advanced monitor (Smart Recovery) |
00690103217957 | HemoSphere Alta advanced monitor (All-on-one) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HEMOSPHERE ALTA 97393729 not registered Live/Pending |
Edwards Lifesciences Corporation 2022-05-03 |