Clovis AI RPM
- Primary DI
- 10850047516043
- Brand
- Clovis AI RPM
- Company
- Remote Smart Health, LLC
- Model
- 12913
- Device description
- Blood Pressure with Micro Aircuff Watch-4G Cellular Case 24 Quantity in a case.
- Published
- 2026-05-26
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | Cardiovascular | 2 |
Premarket Submissions
| Submission | Supplement |
|---|---|
| K182018 | 000 |
Premarket Details
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10850047516043 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10850047516043 | 10850047516043 |
GMDN Terms
| Term | Definition |
|---|---|
| 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. |
Regulatory Flags
- DUNS number
- 093676659
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850047516046 | Clovis AI RPM | 12913 | 2026-05-26 | |
| 00850047516039 | KismeTruth Remote Patient Monitoring | 10109 | 2026-03-19 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 00850047516046 | Clovis AI RPM | Remote Smart Health, LLC | DXN | 2026-05-26 |
| 06920485308412 | PANACARE | Shenzhen BSX Technology Electronics Co., Ltd. | DXN | 2026-05-23 |
| 16942284601461 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601482 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601499 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601505 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601512 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601529 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601864 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 16942284601874 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 16942284601881 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601895 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 16942284601904 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 26942284601987 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 06951727602906 | MBUPAI | Shenzhen Changkun Technology Co., Ltd. | DXN | 2026-03-24 |
| 26970392218445 | SEJOY | JOYTECH HEALTHCARE CO.,LTD | DXN | 2026-03-24 |
| 06975164324436 | Hingmed | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | 2026-03-24 |
| 06975164324535 | Hingmed | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | 2026-03-24 |
| 06975164324542 | Hingmed | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | 2026-03-24 |
| 06975164324610 | Hingmed | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | 2026-03-24 |
| 06975164324627 | Hingmed | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | 2026-03-24 |
| 00816042016356 | FORA | FORA CARE INC. | DXN | 2026-03-20 |
| 06953205995074 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995081 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995098 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995104 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995111 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995128 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995135 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |
| 06953205995142 | Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd | DXN | 2026-03-20 |