MAC 8855002-001

GUDID 00195278276124

MAC 5 A5

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiograph, professional, multichannel
Primary Device ID00195278276124
NIH Device Record Keyef48361d-83e6-4aca-8a2b-0666bace5d99
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAC
Version Model Number5 A5
Catalog Number8855002-001
Company DUNS006580799
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 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
GS100195278276124 [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 Date2022-11-17
Device Publish Date2022-11-09

On-Brand Devices [MAC]

00840682134859600
00840682125499VU360
008406821231125500 HD REMAN
00840682106481800
008406821050712000
008406821048385500 HD
008406821047913500
00195278276124MAC 5 A5
00195278276087MAC 5 Lite
00195278276070MAC 5 A4

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