FDA UDI
In Commercial Distribution
🇺🇸 United States
Avantia BPM-70 Automatic Blood Pressure Monitor
DI: 00775757079301
·
Model: 107-930
·
A.M.G. Médicale Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Avantia BPM-70 Automatic Blood Pressure Monitor
- Primary DI
- 00775757079301
- Version / Model
- 107-930
- Catalog Number
- 107-930
- Company Name
- A.M.G. Médicale Inc
- Labeler DUNS
- 207372814
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-09
- Public Version
- 1
- Public Version Date
- 2023-06-19
- Public Version Status
- New
- Public Device Record Key
- 01715555-3ad0-4bb1-8d69-d1b5c0fcb49e
Device Description
This fully automatic BP monitor for home use is designed with an extra large easy to read screen and offers multi user features for 2 people. The Avantia BPM-70 Automatic Blood Pressure Monitor includes a universal size arm cuff to accommodate a circumference of approximately 8.7” - 16.5” / 22 cm - 42 cm and features a heart rate indicator and date & time indicator. Large screen Dual-user (2 x 60 memories) Heart rate indicator Hypertension risk indicator Date and time indicator AM / PM averaging Universal cuff included
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
- Yes
- 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 |
|---|---|---|---|---|
| 16173 | Automatic-inflation electronic sphygmomanometer, non-portable | An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-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 not designed to be portable and is typically used bedside. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00057565975304 | GS1 | Master Case | 24 | In Commercial Distribution | |
| Primary | 00775757079301 | GS1 |