GUDID 00840682123655

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 00840682123655
• NIH Device Record Key: ba64a4e9-0068-4991-96d6-ec050509c600
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: D4 NEL GOLDSEAL
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682123655 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073462

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: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-04-11

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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• 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
• 00840682106146 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL1, 1 TB MALE SLIP, 03 - 06 CM, SINGLE
• 00840682106160 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL4, 2 TB MALE SLIP, 07 - 13 CM, SINGLE
• 00840682106207 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL5, 2 TB MALE SLIP, 08 - 15 CM, SINGLE