AccessGUDID - DEVICE: NA (00840682115773)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: Remote Alarm Box
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Primary DI Number: 00840682115773
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784985108 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSI	DETECTOR AND ALARM, ARRHYTHMIA

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K001359	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: acd7850d-e51c-46e2-a4f0-2418dc4bf0fe
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 22, 2016