DEVICE: TR BAND (00389701011349)
Device Identifier (DI) Information
TR BAND
TRB24-REG
In Commercial Distribution
TRB24-REG
TERUMO MEDICAL CORPORATION
TRB24-REG
In Commercial Distribution
TRB24-REG
TERUMO MEDICAL CORPORATION
TR BAND Radial Artery Compression Device
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? |
---|---|---|---|---|
35925 | Tourniquet cuff, single-use |
A band-like device that is applied around an extremity (arm or leg) and connected to a tourniquet unit to apply a controlled pressure to restrict blood circulation and prevent normal blood flow to or from the distal area during a surgical intervention or serious injury. The tourniquet unit is used to provide the pressure within the cuff and display the pressure applied. The cuff usually comprises a dual-chamber allowing for alternation of the pressure site to avoid tissue damage or necrosis. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXC | CLAMP, VASCULAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152525 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not store at extreme temperature or humidity |
Special Storage Condition, Specify: Avoid direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 24 Centimeter |
Device Size Text, specify: Contents: Regular Band and 25 mL Inflation Syringe |
Device Record Status
26901729-1eae-4364-b0d3-82b56720cca6
July 06, 2018
3
September 24, 2016
July 06, 2018
3
September 24, 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 |
---|---|---|---|---|---|
50389701011344 | 20 | 30389701011340 | In Commercial Distribution | Carton | |
30389701011340 | 5 | 00389701011349 | In Commercial Distribution | Shelfbox |
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)283-7866
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com