FDA UDI
In Commercial Distribution
🇺🇸 United States
Sharper Image
DI: 00843479189063
·
Model: 1017591
·
Merchsource, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sharper Image
- Primary DI
- 00843479189063
- Version / Model
- 1017591
- Company Name
- Merchsource, LLC
- Labeler DUNS
- 121820737
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-15
- Public Version
- 1
- Public Version Date
- 2023-09-25
- Public Version Status
- New
- Public Device Record Key
- 7d7372d0-3ea7-42c2-b910-5c64ef3037e3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| ISA | Massager, Therapeutic, Electric | Physical Medicine | 890.5660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47888 | Portable sequential venous compression system | A compact portable system designed for the noninvasive treatment and prevention of venous disorders and sequelae (lymphatic, arterial, trauma) by facilitating better vascular flow, as well as minimizing venous stasis during/after surgery and immobilization. It applies sequential pressure to a patient's arm or leg to promote venous blood flow and typically consists of an electrically-powered compression pump, control/timing mechanism, rechargeable batteries, and tubing that connect to an integral cuff or pneumatic stockings that inflate and deflate sequentially. It is normally available [non-prescription] over-the-counter (OTC) for home-use and/or for hospitalized/institutionalized patients. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00843479189063 | GS1 |
Customer Contacts
- Phone
- 18003742744
- [email protected]