FDA UDI
In Commercial Distribution
🇺🇸 United States
Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System
DI: 00850033352009
·
Model: 1168-05
·
DARIOHEALTH CORP.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System
- Primary DI
- 00850033352009
- Version / Model
- 1168-05
- Company Name
- DARIOHEALTH CORP.
- Labeler DUNS
- 116902485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-09
- Public Version
- 3
- Public Version Date
- 2022-06-28
- Public Version Status
- Update
- Public Device Record Key
- a93b384a-5fcc-4293-b3a2-fcd50ac5f019
Device Description
The Dario Smart Monitor (Cellular) - Blood Pressure Monitoring System is digital monitors intended for use in measuring blood pressure. The device can be used to detect irregular heartbeat. It is intended for adult indoor use only
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
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 870.1130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45617 | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850033352009 | GS1 | ||||
| Package | 00850033352016 | GS1 | Box | 10 | In Commercial Distribution |