FDA UDI
In Commercial Distribution
🇺🇸 United States
Resilient Medical Solutions
DI: 00850037100477
·
Model: RMST44SU
·
Resilient Medical Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Resilient Medical Solutions
- Primary DI
- 00850037100477
- Version / Model
- RMST44SU
- Company Name
- Resilient Medical Solutions, LLC
- Labeler DUNS
- 076404432
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-05-22
- Public Version
- 1
- Public Version Date
- 2023-05-30
- Public Version Status
- New
- Public Device Record Key
- 2b54bbed-cc5e-4915-a046-4b6792de1bac
Device Description
Pneumatic Surgical Tourniquet - Sterile, Single-Use, Single Bladder, Dual Port, Size: XXXL, 44", Color: Gray
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QGX | General Use Pneumatic Tourniquet | 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 | 20850037100471 | GS1 | 40 | In Commercial Distribution | ||
| Primary | 00850037100477 | GS1 |