FDA UDI
In Commercial Distribution
🇺🇸 United States
Physiologic essentiA Blood Pressure Monitor
DI: 00057565069362
·
Model: 106-930
·
A.M.G. Médicale Inc
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Physiologic essentiA Blood Pressure Monitor
- Primary DI
- 00057565069362
- Version / Model
- 106-930
- 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
- 2016-09-26
- Public Version
- 6
- Public Version Date
- 2021-10-07
- Public Version Status
- Update
- Public Device Record Key
- 705baf2b-aeb5-4b6c-bc7e-12ffb3b0be4a
Device Description
Large easy to read screen • Multi-user (4 x 30 memories) • Heart rate indicator • Date and time indicator • Large cuff size is available (#106-931) Meets all required Canadian & US FDA Standards including ANSI/AAMI SP-10 & ESH International Protocol Includes: Blood pressure monitor and medium size arm cuff, fits 8.7” to 14.2” (22 to 36 cm) arm circumference Requires 4 AA batteries (not 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 | 05756599154062 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00057565069362 | GS1 | ||||
| Package | 10057565069369 | GS1 | Master case | 12 | In Commercial Distribution |