DEVICE: ACUMEN IQ SENSOR (00690103201130)
Device Identifier (DI) Information
ACUMEN IQ SENSOR
AIQS8S102
In Commercial Distribution
AIQS8S102
Edwards Lifesciences LLC
AIQS8S102
In Commercial Distribution
AIQS8S102
Edwards Lifesciences LLC
ACUMEN IQ SENSOR 84" / 213CM Double Line Kit -- With VAMP
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35927 | Invasive-pressure external transducer, single-use |
A sterile, noninvasive, non-luminal, electronic device designed to be connected to an appropriate invasive luminal device (e.g., catheter, cannula, tube, needle), to detect pressures (e.g., blood, gastrointestinal, urinary pressures) within the lumen and transmit them as electrical signals to an appropriate monitoring device. It consists of a pressure transducer and a connection cable and may be designed to be used with a pressure transducer dome. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DRS | Transducer, Blood-Pressure, Extravascular |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152980 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 84.0000 Inch |
Device Record Status
6e4ae7c5-9dd4-4e03-8f78-f08516b2f4c9
July 17, 2019
1
July 09, 2019
July 17, 2019
1
July 09, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)822-9637
tech_support@edwards.com
tech_support@edwards.com