RespArray ECG limb cable

GUDID 16944413824987

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID16944413824987
NIH Device Record Keyea556a2a-d31b-4aca-9bee-384a4a6d42a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespArray ECG limb cable
Version Model Number01.57.472339
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
GS106944413824980 [Primary]
GS116944413824987 [Package]
Contains: 06944413824980
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 limb cable]

1694441382505201.57.472346
1694441382504501.57.472345
1694441382499401.57.472340
1694441382498701.57.472339
1694441382493201.57.472330
1694441382492501.57.472329
1694441382485701.57.472322
1694441382484001.57.472321
1694441382479601.57.472348
1694441382478901.57.472347
1694441382476501.57.472333
1694441382475801.57.472332

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