AccessGUDID - DEVICE: Remote Alarm (00606959023642)

GUDID

Device Identifier (DI) Information

Brand Name: Remote Alarm
Version or Model: Remote Alarm International
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1120632
Company Name: Respironics, Inc.

Primary DI Number: 00606959023642
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080728314 *Terms of Use

Device Description: Remote Alarm International

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?
35426	Airway pressure alarm	A battery-powered warning device that monitors a patient's upper airway pressure during assisted mechanical ventilation; it typically being connected to the breathing circuit. In the event of either the pressure not rising above a minimum threshold within a maximum time span or exceeding a pre-set maximum level, the device will signal a warning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	VENTILATOR, CONTINUOUS, FACILITY USE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 03868487-157c-4661-89c6-d193277caf15
Public Version Date: February 15, 2021
Public Version Number: 3
DI Record Publish Date: November 02, 2015