3-Lead LTE MCT Monitor ZOLL

GUDID 00811331011562

3-Lead LTE MCT Monitor ZOLL

Tz Medical, Inc.

Telemetric electrocardiographic ambulatory recorder
Primary Device ID00811331011562
NIH Device Record Key9d938c3f-9eab-49ef-bc68-badd5a30bdbe
Commercial Distribution StatusIn Commercial Distribution
Brand Name3-Lead LTE MCT Monitor ZOLL
Version Model NumberH3R-0161
Company DUNS793149709
Company NameTz Medical, 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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811331011562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSIDetector And Alarm, Arrhythmia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-28
Device Publish Date2023-09-20

Devices Manufactured by Tz Medical, Inc.

00811331011470 - ARC Adjustable Radial Cuff2023-11-23 ARC Adjustable Radial Cuff- Large
00811331011333 - ARC Adjustable Radial Cuff2023-11-23 ARC Adjustable Radial Cuff- Small
00811331013917 - H3R USB Cable2023-11-23 H3R USB Cable
00811331013931 - H3R Holster2023-11-23 H3R Holster (Rev A)
00811331013245 - TZ Medical Pressure Discs2023-10-30 Round Universal Disc
00811331011210 - EZ Holder2023-10-30 EZ Holder
00811331011647 - TruBrite Adhesive Retractor Light2023-10-30 Adhesive Retractor Light
00811331011715 - TZ Medical Pressure Discs2023-10-30 Oval Universal Disc

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