DEVICE: TRUWAVE (07460691951990)
Device Identifier (DI) Information
TRUWAVE
50P200R
In Commercial Distribution
50P200R
Edwards Lifesciences LLC
50P200R
In Commercial Distribution
50P200R
Edwards Lifesciences LLC
MALE/MALE LUER LOCK ADAPTOR WITH ROTATING NUT
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? |
---|---|---|---|---|
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 |
60538 | Luer/Luer linear connector, single-use |
A small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. 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 |
---|
No Device Sizes |
Device Record Status
2c412683-e715-4294-a18d-cb0a9c974425
October 23, 2019
5
September 03, 2016
October 23, 2019
5
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 |
---|---|---|---|---|---|
57460691951995 | 50 | 07460691951990 | 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