SpecialsLab

GUDID 00840682123587

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system
Primary Device ID00840682123587
NIH Device Record Keyf0943ba7-f4b0-493f-a02a-cd37ebc4b412
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpecialsLab
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
GS100840682123587 [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

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00840682124683 - NA2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M
00195278421449 - CAM2025-04-15 CAM 14 - MDR
00195278421456 - CAM2025-04-15 CAM HD - MDR
00195278364661 - CardioSoft2025-04-02 CARDIOSOFT V7.0 SP7.2
00195278403643 - CASE2025-04-02 CASE V7.0
00195278617644 - CASE2025-04-02 CASE V7 GENERIC ATO

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