RespArray quick start kit(AHA01)

GUDID 06944413824713

Edan Instruments, Inc.

Electrocardiographic lead set, reusable
Primary Device ID06944413824713
NIH Device Record Keyf555d7fb-0bd3-4211-a552-0ad4b21dc548
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespArray quick start kit(AHA01)
Version Model Number02.01.217622
Company DUNS529173163
Company NameEdan Instruments, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
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
GS106944413824713 [Primary]
GS116944413824710 [Package]
Package: [4 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 Date2022-10-19
Device Publish Date2022-10-11

Devices Manufactured by Edan Instruments, Inc.

06944413815889 - Patient Monitor2024-06-25
06944413815896 - Patient Monitor2024-06-25
06944413815902 - Patient Monitor2024-06-25
06944413813977 - ECG cable2024-06-06
06944413813984 - ECG cable2024-06-06
06944413813991 - ECG cable2024-06-06
06944413814004 - ECG cable2024-06-06
06944413814011 - ECG cable2024-06-06

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