FDA UDI
In Commercial Distribution
🇺🇸 United States
GSO
DI: 06975803530600
·
Model: GDTC2440SS
·
Group Supply Organization Medical Technology(Shanghai) Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- GSO
- Primary DI
- 06975803530600
- Version / Model
- GDTC2440SS
- Company Name
- Group Supply Organization Medical Technology(Shanghai) Ltd
- Labeler DUNS
- 554525912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-06
- Public Version
- 3
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- e5107c45-e685-4832-bd1a-ddbc803b3cef
Device Description
Disposable Tourniquet Cuff, Single Bladder, Single Port, Sterile, Leg, 24X4 in
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | 878.5910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65141 | Arterial tourniquet, pneumatic | An inflatable cuff with fastening mechanism intended to be placed around a patient's limb (arm or leg) and pneumatically inflated from an integrated small gas cartridge to reduce and/or occlude arterial blood circulation to the distal portion of the limb during an emergency situation. It is typically used by emergency medical services (EMS) for emergency blood loss prevention. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16975803530607 | GS1 | box | 15 | In Commercial Distribution | |
| Primary | 06975803530600 | GS1 | ||||
| Package | 26975803530604 | GS1 | case | 4 | In Commercial Distribution |