DEVICE: Edwards Lifesciences Vascular Torniquet Kit (00690103041798)

Device Identifier (DI) Information

Edwards Lifesciences Vascular Torniquet Kit
TK2
In Commercial Distribution
TK2
Edwards Lifesciences LLC
00690103041798
GS1

2
134139174 *Terms of Use
Vascular Torniquet Kit
CLOSE

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?
46852 Extraluminal vascular occluder, single-use
A device intended to be used to mechanically stop or interrupt the flow of blood in veins or arteries temporarily during vascular surgery and emergency trauma surgery. It is typically designed with a ring having a small portion left open so that it can be slipped over the blood vessel to be occluded, or it can have semicircular pivoted arms that can be opened and placed over the vessel with a latch to lock the arms once in place. The inner surface of this ring is lined with a soft-plastic balloon, or pair of balloons, inflated via a connecting tube using a standard syringe. This device facilitates occlusion with minimal trauma to the wall of the blood vessel. This is a single-use device.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
DXC CLAMP, VASCULAR
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K910221 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

5465ea36-692c-482f-94d8-d1e43c214a87
April 08, 2022
4
August 31, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
50690103041793 10 00690103041798 In Commercial Distribution Shipper
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 70690103041797 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)822-9637
tech_support@edwards.com
CLOSE