AccessGUDID - DEVICE: BlackBox RPM (B963BPM201W1)

GUDID

Device Identifier (DI) Information

Brand Name: BlackBox RPM
Version or Model: BPM-201W
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Blackbox Remote Patient Monitoring LLC

Primary DI Number: B963BPM201W1
Issuing Agency: HIBCC
Commercial Distribution End Date: January 01, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 117652799 *Terms of Use

Device Description: Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.

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?
45617	Automatic-inflation electronic sphygmomanometer, portable, arm/wrist	An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-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 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: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
High-level Disinfectant

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: 1da0a14d-613f-4204-a6ee-c314bf66f7ed
Public Version Date: January 01, 2021
Public Version Number: 2
DI Record Publish Date: October 12, 2020