MAC 2030361-023

GUDID 00198953107263

MAC VU360 V3.00 SW UPGRADE

Ge Medical Systems Information Technologies, Inc.

Electrocardiograph, professional, multichannel
Primary Device ID00198953107263
NIH Device Record Key60d78c9a-780e-4c8e-b3c7-90349934f5c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAC
Version Model NumberVU
Catalog Number2030361-023
Company DUNS118935631
Company NameGe Medical Systems Information Technologies, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100198953107263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPSElectrocardiograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-04
Device Publish Date2026-01-27

On-Brand Devices [MAC]

00840682134859600
00840682125499VU360
008406821231125500 HD REMAN
00840682106481800
008406821050712000
008406821048385500 HD
008406821047913500
00195278276124MAC 5 A5
00195278276087MAC 5 Lite
00195278276070MAC 5 A4
00840682144322MAC 7
00198953107263MAC VU360 V3.00 SW UPGRADE

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