FDA UDI
In Commercial Distribution
🇺🇸 United States
Clever Choice
DI: 00850002860221
·
Model: BPM - 850002860221
·
S.D.I. USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Clever Choice
- Primary DI
- 00850002860221
- Version / Model
- BPM - 850002860221
- Catalog Number
- 50002-0860-22
- Company Name
- S.D.I. USA, INC.
- Labeler DUNS
- 116722847
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-30
- Public Version
- 3
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 3d26ecf7-3631-4594-81f1-58ead7d6a387
Device Description
Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10850002860228 | GS1 | Case | 24 | In Commercial Distribution | |
| Primary | 00850002860221 | GS1 |