FDA UDI
In Commercial Distribution
🇺🇸 United States
Resilient Medical Solutions
DI: 00850037100729
·
Model: RMSTYADAP
·
Resilient Medical Solutions, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Resilient Medical Solutions
- Primary DI
- 00850037100729
- Version / Model
- RMSTYADAP
- Company Name
- Resilient Medical Solutions, LLC
- Labeler DUNS
- 076404432
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-16
- Public Version
- 1
- Public Version Date
- 2023-08-24
- Public Version Status
- New
- Public Device Record Key
- 9a72da52-b0a8-41ff-a0e8-ed73ba42ca66
Device Description
Dual to Single Port, Y Shaped Adapter, 5"
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
- 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
- No
- 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 |
|---|---|---|---|---|
| 14074 | Surgical pneumatic tourniquet system | A device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850037100723 | GS1 | 80 | In Commercial Distribution | ||
| Primary | 00850037100729 | GS1 |