GUDID 00840682117425

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00840682117425
• NIH Device Record Key: 5bff519d-09bd-49d1-adcc-cfb3165c0909
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2017842-001
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682117425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071073

FDA Product Code

• MHX: MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-08

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 00195278931504 - MLCL Client Software: 2025-05-13 Software Medical Device GE Client Software V9.0
• 00195278935632 - Mac-Lab: 2025-05-13 AltiX AI.i Mac-Lab Computer
• 00195278935656 - CardioLab: 2025-05-13 AltiX AI.i CardioLab Computer
• 00195278935687 - ComboLab: 2025-05-13 AltiX AI.i ComboLab Computer
• 00195278940193 - MLCL Upgrade: 2025-05-13 Upgrade Kit MLCL V9.0
• 00840682144803 - NA: 2025-05-09 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB 80369-5 DINACLICK FEM, SINGLE
• 00840682118910 - NA: 2025-05-02 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE
• 00840682188968 - MLCL Upgrade: 2025-04-21 Upgrade Kit MLCL V7.1