BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

NA

DI: 00840682115773 · Model: Remote Alarm Box · GE Medical Systems Information Technologies, Inc.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: NA
Primary DI: 00840682115773
Version / Model: Remote Alarm Box
Company Name: GE Medical Systems Information Technologies, Inc.
Labeler DUNS: 006580799
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-07-22
Public Version: 6
Public Version Date: 2026-02-23
Public Version Status: Update
Public Device Record Key: acd7850d-e51c-46e2-a4f0-2418dc4bf0fe
Distribution End Date: 2022-11-17

Device Description

REMOTE ALARM BOX

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: MR Unsafe
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30086	Smoke/fire alarm system	An assembly of electronic devices (e.g., alarms with connecting and interfacing components) integrated into a building, that automatically activate a signal (e.g., audio and/or visual) to indicate detection of smoke and/or extreme heat, as a warning of potential harm to occupants. A device with this capacity is typically used in all facilities occupied by people.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682115773	GS1

Customer Contacts

Phone: +1(800)558-5120
Email: [email protected]

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 0 – 40 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 30 – 90 Percent (%) Relative Humidity
Type: Storage Environment Humidity
Temperature Range: 10 – 95 Percent (%) Relative Humidity
Type: Storage Environment Atmospheric Pressure
Temperature Range: 50 – 106 KiloPascal
Type: Handling Environment Atmospheric Pressure
Temperature Range: 70 – 106 KiloPascal