AccessGUDID - DEVICE: Opal V2C (B628OPALV2C0)

GUDID

Device Identifier (DI) Information

Brand Name: Opal V2C
Version or Model: V2C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPALV2C
Company Name: APDM, INC.

Primary DI Number: B628OPALV2C0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 808473453 *Terms of Use

Device Description: APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.

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?
36252	Kinesiology ambulatory recorder	A battery-powered device designed to continuously measure and record a patient's kinetic activity during routine ambulation, including monitoring the motion of individual joints/limbs, typically to assess joint mobility, gait performance, and fall-risk or frailty (e.g., during post-surgery rehabilitation). It consists of a motion sensor(s) worn on the torso or a limb (e.g., thigh, calf, wrist, ankle) while performing normal daily activities, and a computing device/software to which body movement signals are transmitted for recording/analysis; it may also be attached to or integrated in an external limb prosthesis for activity monitoring.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ISD	Exerciser, Measuring

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
Handling Environment Temperature: between -10 and 50 Degrees Celsius
Storage Environment Temperature: between 10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e26423fe-a8bf-4ff8-9b2b-c849eed13404
Public Version Date: March 05, 2020
Public Version Number: 2
DI Record Publish Date: December 30, 2019