FDA UDI
In Commercial Distribution
🇺🇸 United States
AGE
DI: 06958682800088
·
Model: BA-801
·
AGELESS HEALTH INDUSTRIAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AGE
- Primary DI
- 06958682800088
- Version / Model
- BA-801
- Company Name
- AGELESS HEALTH INDUSTRIAL LIMITED
- Labeler DUNS
- 421298453
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-29
- Public Version
- 4
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- b830d600-6420-424f-98ec-b9cf0517015f
Device Description
Arm type blood pressure monitor, It can can correctly measure arterial blood pressure, must take off the coat for measurement, The cuff of the sphygmomanometer is attached to the left arm,It is very suitable for use in the family
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|---|---|
| Primary | 06958682800088 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123882 | 000 |