FDA UDI
In Commercial Distribution
🇺🇸 United States
Tourniquet Drape; small
DI: 04250105630251
·
Model: 24-00-100-1
·
VBM Medizintechnik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Tourniquet Drape; small
- Primary DI
- 04250105630251
- Version / Model
- 24-00-100-1
- 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
- 368f8618-0905-4c15-82d8-bf7a0e15d467
Device Description
18 - 45 cm
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | 878.5910 | 1 |
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 | 14250105630258 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 04250105630251 | GS1 | ||||
| Previous | 04250105620474 | GS1 |
Customer Contacts
- Phone
- +49745495960
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, keep away from sunlight and heat