AccessGUDID - DEVICE: Hokanson (00817065021532)

GUDID

Device Identifier (DI) Information

Brand Name: Hokanson
Version or Model: 5.40
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03417
Company Name: D.E.HOKANSON, INC.

Primary DI Number: 00817065021532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071829634 *Terms of Use

Device Description: ARTERIAL AND VENOUS EXAM, W/DOPPLER SPECTRA SOFTWARE - 220V - Software that connects to several noninvasive physiologic instruments that captures and stores waveforms and blood pressures generated by those instruments, to be viewed on a computer and recorded in the database for analysis by a clinician. Reports are generated which list patient history information, recorded waveforms and blood pressures. Study results are used by the clinician to assess peripheral vascular disease diagnosis in the patient. Includes interface box to connect computer to physiologic instruments and 220V mains.

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?
47688	Peripheral vascular haemodynamic measurement application software	An application software program designed for use with a noninvasive peripheral vascular haemodynamic measuring device (e.g., cardiovascular-risk peripheral arterial tonometry system, plethysmograph, sphygmomanometer) to enable the management and/or analysis of data; it may also support control of the device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQK	Computer, Diagnostic, Programmable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K970570	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 72cf5b7c-be56-415e-9bff-fdcc4d531499
Public Version Date: October 02, 2020
Public Version Number: 5
DI Record Publish Date: September 16, 2016