AccessGUDID - DEVICE: LIFENET PC Gateway (00883873908181)

GUDID

Device Identifier (DI) Information

Brand Name: LIFENET PC Gateway
Version or Model: 21340
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21340-000769
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873908181
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: LIFENET PC Gateway RELEASE 5.3.3

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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):	No
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?
44083	Emergency/ambulatory healthcare software	A software program intended to support the administrative and clinical activities associated with the provision and utilization of emergency medical services (EMS), emergency social services (ESS), and/or public safety facilities. It typically allows for communication of patient physiological data to facilitate activities such as on-line consultation between EMS and clinician, and hospital preparation for emergency patients.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MSX	SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 625684dd-a856-43d0-b7cf-cafe4d68ecad
Public Version Date: April 06, 2020
Public Version Number: 4
DI Record Publish Date: October 30, 2015