NIBP CUFF

GUDID 06944413811874

Edan Instruments, Inc.

Blood pressure cuff, reusable
Primary Device ID06944413811874
NIH Device Record Key7c26223e-ff45-455e-b67f-7dda60b7ff94
Commercial Distribution StatusIn Commercial Distribution
Brand NameNIBP CUFF
Version Model Number01.57.471907
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413811874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQBlood Pressure Cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-09
Device Publish Date2021-02-01

On-Brand Devices [NIBP CUFF]

06944413804821Neonatal, 6cm-11cm, reusable
06944413804814Neonatal, 10cm-15cm, reusable
06944413804616Thigh, 42cm-54cm,reusable
06944413804609Larger Adult, 34cm-43cm, reusable
06944413804593Adult,27cm-35cm, reusable
06944413804586Small adult,20.5cm-28cm, reusable
06944413804579Child,16cm-21.5cm, reusable
06944413804562Small Child,13cm-17cm, reusable
06944413804555Infant,10cm-15cm, reusable
06944413804548Thigh, 42cm-54cm, reusable
06944413804531Larger Adult, 34cm-43cm, reusable
06944413804524Adult,27cm-35cm, reusable
06944413804517Small adult,20.5cm-28cm, reusable
06944413804500Child,16cm-21.5cm, reusable
06944413804494Child,13cm-17cm, reusable
06944413804487Infant,10cm-15cm, reusable
0694441381187401.57.471907

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