ZIO SR Patch

GUDID 00869770000234

ZIO SR ECG Monitoring Service

IRHYTHM TECHNOLOGIES, INC.

Electrocardiographic ambulatory recorder
Primary Device ID00869770000234
NIH Device Record Keyd24a589c-828f-4dc6-8360-4fbe2cff7866
Commercial Distribution Discontinuation2017-05-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZIO SR Patch
Version Model NumberK100A101X
Company DUNS861237670
Company NameIRHYTHM TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100869770000234 [Primary]

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-19

Devices Manufactured by IRHYTHM TECHNOLOGIES, INC.

00850043907046 - Zio ECG Utilization Software (ZEUS) System2024-08-05
00869770000241 - Zio monitor2022-05-11
00869770000210 - ZIO AT Patch2019-11-08 ZIO AT ECG Monitoring Service
00869770000203 - ZIO XT Patch2019-11-08 ZIO XT ECG Monitoring Service
00869770000234 - ZIO SR Patch2019-11-08ZIO SR ECG Monitoring Service
00869770000234 - ZIO SR Patch2019-11-08 ZIO SR ECG Monitoring Service

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