FDA UDI
In Commercial Distribution
🇺🇸 United States
Electronic Blood Pressure Monitor
DI: 06933257914063
·
Model: YE660E
·
Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Electronic Blood Pressure Monitor
- Primary DI
- 06933257914063
- Version / Model
- YE660E
- Catalog Number
- YE660E
- Company Name
- Jiangsu Yuyue Medical Equipment & Supply Co.,Ltd.
- Labeler DUNS
- 528704000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-27
- Public Version
- 1
- Public Version Date
- 2021-02-04
- Public Version Status
- New
- Public Device Record Key
- a3ebe60b-cb8a-484b-b25e-7c5c786aff76
Device Description
The measuring method for the Upper Arm Type Electronic Blood Pressure Monitor Series is oscillation mensuration. The subject devices will automatically start to take measurements after the inflation of the cuff is finished, the results will show the systolic pressure and diastolic pressure with pulse rate. The blood pressure monitor will store the measurements automatically; the time, date, blood pressure value and pulse value are included. The record maybe revisited.
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 | 06933257914063 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K200939 | 000 |