Flexmed

GUDID 00860000853118

RBD GROUP, LLC

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Primary Device ID00860000853118
NIH Device Record Key7c06e2e5-6c0d-4987-8f85-354f00c6db9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexmed
Version Model NumberRBD001
Company DUNS116729960
Company NameRBD GROUP, 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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000853118 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-08
Device Publish Date2019-03-15

On-Brand Devices [Flexmed]

00860000853125RBD002
00860000853118RBD001
00860000853101RBD003

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