AccessGUDID - DEVICE: Digistat Smart Central (17350097870032)

GUDID

Device Identifier (DI) Information

Brand Name: Digistat Smart Central
Version or Model: SW000754
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ASCOM UMS SRL

Primary DI Number: 17350097870032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 429174886 *Terms of Use

Device Description: Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.

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):	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?
40573	Alarm application software	An individual software application program or group of programs, routines or algorithms designed for use in, or together with, an alarm device to enable it to function according to its intended purpose. The basic set of applications programs and routines can be upgraded to correct programming errors or to add new system capabilities. Application program packages are typically identified by a proprietary name and "version" or "upgrade" number. This software may also be produced for installation in an off-the-shelf desktop or laptop computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHC	Infusion Safety Management Software
MSX	System, Network And Communication, Physiological Monitors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K180430	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d58b40f0-ad0e-4ddd-9be5-86a73d6ee9da
Public Version Date: March 25, 2019
Public Version Number: 1
DI Record Publish Date: March 15, 2019