FDA UDI
In Commercial Distribution
🇺🇸 United States
TR BAND
DI: 00389701011349
·
Model: TRB24-REG
·
TERUMO MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- TR BAND
- Primary DI
- 00389701011349
- Version / Model
- TRB24-REG
- Catalog Number
- TRB24-REG
- Company Name
- TERUMO MEDICAL CORPORATION
- Labeler DUNS
- 131489882
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 26901729-1eae-4364-b0d3-82b56720cca6
Device Description
TR BAND Radial Artery Compression Device
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXC | CLAMP, VASCULAR | Cardiovascular | 870.4450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50389701011344 | GS1 | Carton | 20 | In Commercial Distribution | |
| Package | 30389701011340 | GS1 | Shelfbox | 5 | In Commercial Distribution | |
| Primary | 00389701011349 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152525 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 24 | Centimeter | |
| Device Size Text, specify | Contents: Regular Band and 25 mL Inflation Syringe |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at extreme temperature or humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid direct sunlight