FDA UDI
In Commercial Distribution
🇺🇸 United States
HOMEDICS
DI: 00031262105936
·
Model: BPM-700
·
FKA DISTRIBUTING CO., LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- HOMEDICS
- Primary DI
- 00031262105936
- Version / Model
- BPM-700
- Company Name
- FKA DISTRIBUTING CO., LLC
- Labeler DUNS
- 183280973
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-24
- Public Version
- 2
- Public Version Date
- 2022-08-01
- Public Version Status
- Update
- Public Device Record Key
- a2876715-6191-4f62-8ab1-fbfded8f07fe
Device Description
manual arm blood pressure monitor
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
- 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 |
|---|---|---|---|---|
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16156 | Aneroid manual sphygmomanometer | A device designed to measure blood pressure consisting of an inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. The aneroid manometer consists of a metal bellows, which expands as the pressure in the cuff increases, and a mechanical amplifier that transmits this expansion through a lever to an indicator needle, which rotates around a circular, calibrated scale. The manometer may be mounted to a wall, placed on a table, or hand held (portable); blood pressure measurement is taken in conjunction with a stethoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10031262105933 | GS1 | 6 | In Commercial Distribution | ||
| Primary | 00031262105936 | GS1 | ||||
| Package | 20031262105930 | GS1 | 6 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190902 | 000 |