AccessGUDID - DEVICE: Finger Plethysmograph (Model MC2, AngioNew® V& VI) (00817980021204)

GUDID

Device Identifier (DI) Information

Brand Name: Finger Plethysmograph (Model MC2, AngioNew® V& VI)
Version or Model: Model AngioNew VI
Commercial Distribution Status: In Commercial Distribution
Catalog Number: V23-0007
Company Name: VASOMEDICAL, INC.

Primary DI Number: 00817980021204
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 197210248 *Terms of Use

Device Description: Finger Plethysmograph (Model MC2, AngioNew® V& VI)

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):	Yes
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
DRN	Device, counter-pulsating, external

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033617	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: 4c196a74-4c6c-4876-9e5a-769fd8fbbd2e
Public Version Date: April 04, 2023
Public Version Number: 4
DI Record Publish Date: November 29, 2016