AccessGUDID - DEVICE: Sensis Vibe Combo (04056869010205)

GUDID

Device Identifier (DI) Information

Brand Name: Sensis Vibe Combo
Version or Model: 11007642
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Siemens Healthcare GmbH

Primary DI Number: 04056869010205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313217003 *Terms of Use

Device Description: Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22

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?
10980	Cardiac catheterization laboratory computer	A dedicated computer designed to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. The computer may store these values chronologically, along with other physiologic events that occur during the procedure. This GMDN code may reflect old technology; its functions may be performed using off-the-shelf computer ware and dedicated software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Humidity: between 20 and 75 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 392a1813-589b-42a4-9b17-73d007565949
Public Version Date: January 13, 2025
Public Version Number: 7
DI Record Publish Date: February 13, 2017