MURAL PERINATAL SURVEILLANCE K1770PTED

GUDID 00195278726391

MD MURAL PERINATAL SURVEILLANCE 2.2 MEDICAL DEVICE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient health record information system
Primary Device ID00195278726391
NIH Device Record Key3aaf4820-e904-4877-b674-dd9b14064532
Commercial Distribution StatusIn Commercial Distribution
Brand NameMURAL PERINATAL SURVEILLANCE
Version Model Number2.2
Catalog NumberK1770PTED
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 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
GS100195278726391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HGMSystem, monitoring, perinatal

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-06-10
Device Publish Date2024-05-31

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

00840682144803 - NA2025-05-09 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB 80369-5 DINACLICK FEM, SINGLE
00840682118910 - NA2025-05-02 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE
00840682188968 - MLCL Upgrade2025-04-21 Upgrade Kit MLCL V7.1
00840682124669 - NA2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 2.4M
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.