AccessGUDID - DEVICE: Blood Volume Pulse Sensor (NB-BVP-F) (08719481550035)

GUDID

Device Identifier (DI) Information

Brand Name: Blood Volume Pulse Sensor (NB-BVP-F)
Version or Model: 1.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mind Media Europe B.V.

Primary DI Number: 08719481550035
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 494765181 *Terms of Use

Device Description: NB-BVP-F (finger module): The BVP sensor provides a photoplethysmography (PPG) signal when connected to a NeXus signal acquisition device, that corresponds with variations in peripheral blood flow resulting from cardiovascular activity and responses, with the purpose of providing information on the cardiovascular variations such as heart rate variations and measured pulse amplitude. The sensor output is not intended to be used for vital monitoring purposes. The device is designed for medical use, not restricted to a specific medical indication, for acquisition of physiological signals. The device is intended to be used by, or under supervision of, a health professional within a clinical environment.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
62331	Plethysmography phototransducer	A photoelectric sensor designed to be applied externally to a body area (e.g., limb, fingertip, toe, sacral region) for the transcutaneous measurement of blood volume changes using light detection. It is intended to be connected to a parent device (e.g., limb plethysmograph, pressure ulcer risk assessment analyser) whereby volume changes are displayed graphically to represent blood flow/pulse, typically for vascular function assessment in a limb [e.g., measurement of toe brachial pressure index], or to assess a patient’s risk of developing pressure ulcers. Although similar to a pulse oximeter probe it is not capable of oxygen saturation measurements. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

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: 7b166b55-43ed-476b-be3c-24175fd5994d
Public Version Date: February 08, 2024
Public Version Number: 3
DI Record Publish Date: July 19, 2021