Device
PulseGuardOne Bluetooth Blood Pressure Monitor for non-invasive measurement of blood pressure and pulse rate for home use
Manufacturer
Maxmed USA Inc.
Maxmed USA Inc.
Model: MM-BP-5000
DI: 00199874034737
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-14
Current Version: 2026-05-22
Description
PulseGuardOne Bluetooth Blood Pressure Monitor for non-invasive measurement of blood pressure and pulse rate for home use
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
17b82c94-3bec-4207-bcf9-a9aeefe05a1e
Distribution Status:
In Commercial Distribution
DUNS Number:
119543902
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00199874034737
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 16156
Name: Aneroid manual sphygmomanometer
Definition:
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.
FDA Product Codes
DXN
System, Measurement, Blood-Pressure, Non-Invasive
Premarket Submissions
Submission Number:
K260276
Supplement Number:
000