FDA UDI
In Commercial Distribution
🇺🇸 United States
Tourniquet Silicone Cuff; Single Cuff
DI: 14250105630104
·
Model: 20-64-611
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Tourniquet Silicone Cuff; Single Cuff
- Primary DI
- 14250105630104
- Version / Model
- 20-64-611
- Company Name
- VBM Medizintechnik GmbH
- Labeler DUNS
- 324869601
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-27
- Public Version
- 1
- Public Version Date
- 2024-07-05
- Public Version Status
- New
- Public Device Record Key
- b4db353a-da60-4d2b-9987-da9fe9d62455
Device Description
35 cm / 14 inch
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | 878.5910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17230 | Tourniquet cuff, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 04250105630107 | GS1 | ||||
| Primary | 14250105630104 | GS1 | ||||
| Previous | 04250105619799 | GS1 |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter | |
| Length | 14 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry, keep away from sunlight and heat