DEVICE: TR BAND (00389701011349)

Device Identifier (DI) Information

TR BAND
TRB24-REG
In Commercial Distribution
TRB24-REG
TERUMO MEDICAL CORPORATION
00389701011349
GS1

1
131489882 *Terms of Use
TR BAND Radial Artery Compression Device
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
DXC CLAMP, VASCULAR
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K152525 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Do not store at extreme temperature or humidity
Special Storage Condition, Specify: Avoid direct sunlight
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Clinically Relevant Size

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Size Type Text
Length: 24 Centimeter
Device Size Text, specify: Contents: Regular Band and 25 mL Inflation Syringe
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Device Record Status

26901729-1eae-4364-b0d3-82b56720cca6
July 06, 2018
3
September 24, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
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