FDA UDI
In Commercial Distribution
🇺🇸 United States
higi SZZT
DI: B146ZT2776A00210
·
Model: ZT2776A0021
·
HIGI SH LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- higi SZZT
- Primary DI
- B146ZT2776A00210
- Version / Model
- ZT2776A0021
- Catalog Number
- n/a
- Company Name
- HIGI SH LLC
- Labeler DUNS
- 079773850
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 2
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 6f0a04d2-6de3-4598-9d25-9e622a309d43
Device Description
The higi Station is intended for use by the general public to measure blood pressure, pulse, body weight, percent body fat, percent lean body mass, total body water and calculate body mass index. It is not a diagnostic device and only furnishes data so that users can consult their personal physician or other healthcare professional. The user can choose to store or send the data to a personal physician or healthcare professional. Users must be 13 years of age to use the higi Station.
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | B146ZT2776A00210 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172739 | 000 |