Telemetry Transmitter

GUDID 06944413802278

Edan Instruments, Inc.

Single-patient intensive/general healthcare physiologic monitoring system
Primary Device ID06944413802278
NIH Device Record Key86ff7801-64ce-4133-8e40-d6926a072a2e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTelemetry Transmitter
Version Model NumberiT20
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 Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106944413802261 [Primary]
GS106944413802278 [Package]
Contains: 06944413802261
Package: [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2017-02-22

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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