AccessGUDID - DEVICE: Ozeri (00815817012685)

GUDID

Device Identifier (DI) Information

Brand Name: Ozeri
Version or Model: BP6T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BP6T
Company Name: COMMONPATH LLC

Primary DI Number: 00815817012685
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963223677 *Terms of Use

Device Description: Ozeri Cardio Tech, Travel series. LEss than 1" inch(2.5cm) thick and 3.5 oz(100g). New MWI(Measure white inflate) technology. 399 x 3 users.

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?
16986	Automatic-inflation electronic sphygmomanometer, portable, finger	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic finger-cuff inflation and measurement cycles. The cuff detects minute arterial volume changes in conjunction with an inflatable bladder which exerts pressure (counterpressure) just sufficient to equal the arterial pressure. The device typically displays current heart rate in addition to systolic and diastolic blood pressures. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	System, Measurement, Blood-Pressure, Non-Invasive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: ab82ccf5-0ff0-4763-867a-112937f6d76b
Public Version Date: November 08, 2019
Public Version Number: 3
DI Record Publish Date: May 23, 2017