AMS PROOF

GUDID 00197644700561

HIGH BLOOD PRESSURE MONITOR

American Medical Solutions LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00197644700561
NIH Device Record Keya9b93c3d-bf76-4f9a-b1fc-982d6086f0ac
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMS PROOF
Version Model NumberJPD-HA101
Company DUNS118331001
Company NameAmerican Medical Solutions LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100197644700561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.