GUDID 00840682115773

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Smoke/fire alarm system

• Primary Device ID: 00840682115773
• NIH Device Record Key: acd7850d-e51c-46e2-a4f0-2418dc4bf0fe
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Remote Alarm Box
• 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: 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

Customer Support Contacts

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

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682115773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001359

FDA Product Code

• DSI: DETECTOR AND ALARM, ARRHYTHMIA

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: 2016-07-22

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 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
• 00840682106269 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL3, 2 TB MALE SLIP, 06 - 11 CM, SINGLE
• 00840682106375 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL2, 2 TB MALE SLIP, 04 - 08 CM, SINGLE
• 00840682106665 - SOFT-CUF: 2025-05-16 SOFT-CUF, NEONATAL3, 1 TB MALE SLIP, 06 - 11 CM, SINGLE