AccessGUDID - DEVICE: TekCare Blood Pressure Monitor (04710953421338)

GUDID

Device Identifier (DI) Information

Brand Name: TekCare Blood Pressure Monitor
Version or Model: BPM19
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AVITA CORPORATION

Primary DI Number: 04710953421338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658023275 *Terms of Use

Device Description: BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and heart rate. All values are shown on the LCD monitor. This device is designed only for adults.

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):	Yes
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?
16173	Automatic-inflation electronic sphygmomanometer, non-portable	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.	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: 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
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dcaf65c1-ec35-4ed8-a18b-eff56ec5c240
Public Version Date: November 08, 2019
Public Version Number: 2
DI Record Publish Date: December 31, 2018