AccessGUDID - DEVICE: MULTITECH 3G GATEWAY

GUDID

Device Identifier (DI) Information

Brand Name: MULTITECH 3G GATEWAY - INTL
Version or Model: 21996
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 21996-000108
Company Name: PHYSIO-CONTROL, INC.

Primary DI Number: 00883873863046
Issuing Agency: GS1
Commercial Distribution End Date: July 14, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 009251992 *Terms of Use

Device Description: MULTITECH 3G GATEWAY - INTL

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):	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: 62427318-07fc-41a9-8c53-97e01bb2f9bf
Public Version Date: April 06, 2020
Public Version Number: 3
DI Record Publish Date: February 01, 2016