AccessGUDID - DEVICE: Vivifyhealth SK005 (00850032055185)

GUDID

Device Identifier (DI) Information

Brand Name: Vivifyhealth SK005
Version or Model: SK005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Vivify Health, Inc.

Primary DI Number: 00850032055185
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 833028959 *Terms of Use

Device Description: Service Kit SK005 Omron BP Monitor Omron Cuff

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?
64338	Multiparameter physiologic analysis workstation	A computerized unit intended to be used with a variety of noninvasive sensors (not included) for the non-continuous measurement of a variety of cardiovascular and pulmonary parameters [e.g., blood pressure, electrocardiography (ECG), SpO2, lung volume, airway resistance]; it might also be intended for additional physiologic analysis [e.g., electromyography (EMG), galvanic skin response (GSR)]. It includes sensor inputs, controls (e.g., touchscreen) and is intended to allow viewing, sharing and storage of the data; it is neither intended for continuous monitoring nor stress exercise monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222398	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: cef35bd4-0194-4817-9a43-f60ea3ce7cae
Public Version Date: August 26, 2024
Public Version Number: 3
DI Record Publish Date: February 19, 2024