DEVICE: TRUWAVE (07460691959651)
Device Identifier (DI) Information
TRUWAVE
59L3WSC
In Commercial Distribution
59L3WSC
Edwards Lifesciences LLC
59L3WSC
In Commercial Distribution
59L3WSC
Edwards Lifesciences LLC
PRESSURE MONITORING ACCESSORY
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
35375 | Stopcock |
A general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXO | TRANSDUCER, PRESSURE, CATHETER TIP |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K142749 | 000 |
K171996 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: STORE IN A COOL, DRY PLACE. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 3 WAY STOPCOCK |
Device Record Status
19ca1e72-7265-48d3-bb4c-deb486326478
August 21, 2018
4
September 03, 2016
August 21, 2018
4
September 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
57460691959656 | 20 | 07460691959651 | In Commercial Distribution | Shipper |
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