TR BAND TRB24-REG
GUDID 00389701012469
TR BAND Radial Artery Compression Device
TERUMO MEDICAL CORPORATION
Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use Tourniquet cuff, single-use| Primary Device ID | 00389701012469 |
| NIH Device Record Key | ad485bfa-9c45-4a44-8b55-2af21526346a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TR BAND |
| Version Model Number | TRB24-REG |
| Catalog Number | TRB24-REG |
| Company DUNS | 131489882 |
| Company Name | TERUMO MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com | |
| Phone | +1(800)283-7866 |
| tmccustomer.admin@terumomedical.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
| Device Size Text, specify | 0 |
| Length | 24 Centimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store at extreme temperature and humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Avoid direct sunlight. Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00389701012469 [Primary] |
| GS1 | 30389701012460 [Package] Package: [5 Units] In Commercial Distribution |
| GS1 | 50389701012464 [Package] Contains: 30389701012460 Package: [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213531
FDA Product Code
| DXC | CLAMP, VASCULAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-17 |
| Device Publish Date | 2022-10-07 |
On-Brand Devices [TR BAND]
| 50389701011351 | TR BAND Radial Artery Compression Device |
| 50389701011344 | TR BAND Radial Artery Compression Device |
| 00389701012476 | TR BAND Radial Artery Compression Device |
| 00389701012469 | TR BAND Radial Artery Compression Device |
Trademark Results [TR BAND]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TR BAND 85842085 4517090 Live/Registered |
Terumo Kabushiki Kaisha 2013-02-06 |
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