FDA UDI
Not in Commercial Distribution
🇺🇸 United States
QuantaFlo
DI: 00859433006024
·
Model: 91-0010
·
SEMLER SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- QuantaFlo
- Primary DI
- 00859433006024
- Version / Model
- 91-0010
- Company Name
- SEMLER SCIENTIFIC, INC.
- Labeler DUNS
- 968030333
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 4
- Public Version Date
- 2022-06-02
- Public Version Status
- Update
- Public Device Record Key
- 1a5031b8-9df4-4849-b5f3-65c3a9843abd
- Distribution End Date
- 2018-05-18
Device Description
USB Sensor
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | Cardiovascular | 870.2780 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13056 | Limb plethysmograph | A graphic recorder designed for determining and registering volume variations in the extremities (legs/toes and/or arms/fingers) as modified by the circulation of blood through them. It typically consists of flow and/or volume sensors and transducers attached to an electronic unit, which processes the data and displays the results. It may operate using one of several methods including venous occlusion (pneumatic), photoelectric, electrical impedance, or strain gauge. The device is typically used in peripheral vascular diagnostic investigations [e.g., for deep vein thrombosis (DVT) or arterial occlusive disease]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859433006024 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K143094 | 000 |