CS

GUDID 00840682105156

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac stress exercise monitoring system

• Primary Device ID: 00840682105156
• NIH Device Record Key: 536a6361-85ef-4e64-8ce6-18dbd0a4a9ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS
• Version Model Number: V6.73
• Company DUNS: 784985108
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx
• Phone: +1(800)558-7044
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682105156 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103678

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-05-13

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 00198953107263 - MAC: 2026-02-04 MAC VU360 V3.00 SW UPGRADE
• 00195278990914 - Portrait CSSXB: 2025-12-18 PORTRAIT CORE SERVICES SOFTWARE V1.2.0
• 00198953024096 - Portrait CVAXB: 2025-12-18 Portrait Central Viewer Application Installer V1.2.0
• 00840682144292 - CARESCAPE: 2025-06-12 V100 GENERIC ATO MODEL No CE
• 00840682119030 - NA: 2025-05-22 SOFT-CUF, LARGE ADULT LONG, 2 TB INFLATION SYSTEM, 31 - 40 CM, SINGLE
• 00840682119085 - NA: 2025-05-22 SOFT-CUF, SMALL ADULT, 2 TB INFLATION SYSTEM, 17 - 25 CM, SINGLE
• 00840682106009 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL1, 2 TB MALE SLIP, 03 - 06 CM, SINGLE
• 00840682106122 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL2, 1 TB MALE SLIP, 04 - 08 CM, SINGLE