Primary Device ID | 00690103191165 |
NIH Device Record Key | bf96cab3-249d-404f-817a-90d6d9d4b2cc |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 64EKSM |
Catalog Number | 64EKSM |
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 | false |
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 | |
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 |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
Length | 9 Feet |
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. |
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 | 00690103191165 [Primary] |
DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-03 |
00690103219265 - FLOTRAC | 2024-08-14 FLOTRAC SENSOR JR |
00690103219357 - FLOTRAC | 2024-08-14 FLOTRAC SENSOR JR |
50690103219383 - SWAN-GANZ | 2024-08-13 Swan-Ganz Thermodilution Pediatric |
50690103200985 - ACUMEN IQ SENSOR | 2024-07-26 ACUMEN IQ SENSOR W/ VAMP ADULT 60"/152cm 5-Pack |
50690103201005 - Acumen IQ | 2024-07-26 ACUMEN IQ SENSOR 60" / 152CM Double Line Kit -- With VAMP |
50690103201012 - ACUMEN IQ SENSOR | 2024-07-26 ACUMEN IQ SENSOR 84" / 213CM Double Line Kit - No VAMP |
00690103219401 - 1141M MITRIS RESILIA Mitral Valve Handle | 2024-07-18 STAINLESS STEEL REUSABLE HANDLE FOR MITRIS |
00690103217124 - HemoSphere Vita | 2024-03-05 PRESSURE CONTROLLER KIT |