Mac-Lab

GUDID 00840682123556

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system
Primary Device ID00840682123556
NIH Device Record Keye672ae60-6306-441c-91e8-8a51584c5103
Commercial Distribution StatusIn Commercial Distribution
Brand NameMac-Lab
Version Model Numberv6.9.6 R3
Company DUNS784985108
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
GS100840682123556 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-07-11

On-Brand Devices [Mac-Lab]

00840682145985A1
00840682123556v6.9.6 R3

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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