FDA UDI
In Commercial Distribution
🇺🇸 United States
iBloodPressure
DI: 00869876000053
·
Model: SMBP802-GS-001
·
SMART METER LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iBloodPressure
- Primary DI
- 00869876000053
- Version / Model
- SMBP802-GS-001
- Catalog Number
- 06BPSM5000USAL
- Company Name
- SMART METER LLC
- Labeler DUNS
- 117014140
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-29
- Public Version
- 2
- Public Version Date
- 2020-11-18
- Public Version Status
- Update
- Public Device Record Key
- ccff3091-5103-4171-9628-b9272f1bddc3
Device Description
iBloodPressure Cellular Blood Pressure Monitor, Adult, Large
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 | 00869876000053 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K123780 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 42 | Centimeter | |
| Circumference | 22 | Centimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- – 93 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius