RespArray NIBP cuff

GUDID 06944413839434

Edan Instruments, Inc.

Blood pressure cuff, reusable
Primary Device ID06944413839434
NIH Device Record Keydcc7b954-559c-4371-be97-7fa3c291e924
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespArray NIBP cuff
Version Model Number02.57.225242
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413839434 [Primary]
GS116944413839431 [Package]
Package: [10 Units]
In Commercial Distribution

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 Date2024-04-29
Device Publish Date2024-04-19

On-Brand Devices [RespArray NIBP cuff]

0694441382481201.57.472318
0694441382480501.57.472317
0694441383949602.57.225235
0694441383948902.57.225234
0694441383947202.57.225233
0694441383946502.57.225232
0694441383945802.57.225240
0694441383944102.57.225241
0694441383943402.57.225242

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