AccessGUDID - DEVICE: Finapres (08719327003770)

GUDID

Device Identifier (DI) Information

Brand Name: Finapres
Version or Model: Finger cuff size Large NC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP_400224
Company Name: Finapres Medical Systems B.V.

Primary DI Number: 08719327003770
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 489470686 *Terms of Use

Device Description: Finger cuff size Large NC

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?
36551	Patient monitoring system module, blood pressure, noninvasive	A small unit dedicated to the measurement of noninvasive blood pressure (indirect method) obtained through a standard sphygmomanometer cuff placed on the arm or leg. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive
DQA	Oximeter
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
DSB	Plethysmograph, Impedance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173916	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: f72e75a9-c086-47e4-98e7-8c1ef43b25cf
Public Version Date: December 31, 2018
Public Version Number: 1
DI Record Publish Date: November 30, 2018