Mac-Lab 2400000-003

GUDID 00195278935632

AltiX AI.i Mac-Lab Computer

Ge Medical Systems Information Technologies, Inc.

Cardiac catheterization monitoring system
Primary Device ID00195278935632
NIH Device Record Key4d608dd4-c640-4816-9a31-3aa5ddff0ed8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMac-Lab
Version Model NumberAltiX AI.i
Catalog Number2400000-003
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 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
GS100195278935632 [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 [Mac-Lab]

00840682145985A1
00840682123556v6.9.6 R3
00195278935632AltiX AI.i Mac-Lab Computer

Trademark Results [Mac-Lab]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MAC-LAB
MAC-LAB
74606003 1939749 Live/Registered
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
1994-11-09

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