RespArray ECG whole cable

GUDID 16944413825021

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID16944413825021
NIH Device Record Key03b647c7-0693-4549-9a85-8cb427be8a65
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespArray ECG whole cable
Version Model Number01.57.472343
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS106944413825024 [Primary]
GS116944413825021 [Package]
Contains: 06944413825024
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-09
Device Publish Date2022-09-01

On-Brand Devices [RespArray ECG whole cable]

0694441382619901.57.472398
0694441382618201.57.472397
0694441382617501.57.472396
0694441382616801.57.472395
1694441382509001.57.472352
1694441382508301.57.472351
1694441382507601.57.472350
1694441382506901.57.472349
1694441382503801.57.472344
1694441382502101.57.472343
1694441382501401.57.472342
1694441382500701.57.472341
1694441382497001.57.472337
1694441382496301.57.472336
1694441382495601.57.472335
1694441382494901.57.472334
1694441382489501.57.472326
1694441382488801.57.472325
1694441382487101.57.472324
1694441382486401.57.472323

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