MLCL Upgrade 5973644

GUDID 00195278940193

Upgrade Kit MLCL V9.0

Ge Medical Systems Information Technologies, Inc.

Cardiac electrophysiology analysis system
Primary Device ID00195278940193
NIH Device Record Keyc2a99c4c-0518-498d-b154-dcff5e137467
Commercial Distribution StatusIn Commercial Distribution
Brand NameMLCL Upgrade
Version Model NumberAltiX AI.i
Catalog Number5973644
Company DUNS118935631
Company NameGe Medical Systems Information Technologies, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278940193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, Diagnostic, Programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-13
Device Publish Date2025-05-05

On-Brand Devices [MLCL Upgrade]

00195278516015Upgrade Kit MLCL V8.0
00840682188968Upgrade Kit MLCL V7.1
00195278940193Upgrade Kit MLCL V9.0

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