MGC Diganostics

GUDID B3688008100310

Ultima System CPX - 230V UPS

MEDICAL GRAPHICS CORPORATION

Cardiopulmonary stress exercise monitoring system
Primary Device IDB3688008100310
NIH Device Record Key3e5839d6-82eb-478e-9708-fbcd74d1618f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMGC Diganostics
Version Model Number800810-031
Company DUNS094045622
Company NameMEDICAL GRAPHICS CORPORATION
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
HIBCCB3688008100310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZLComputer, Oxygen-Uptake

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-19
Device Publish Date2018-06-18

Devices Manufactured by MEDICAL GRAPHICS CORPORATION

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