AccessGUDID - DEVICE: Parallel(TM) (00860006172008)

GUDID

Device Identifier (DI) Information

Brand Name: Parallel(TM)
Version or Model: 01-0001-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-0001-001
Company Name: Mahana Therapeutics, Inc.

Primary DI Number: 00860006172008
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081128158 *Terms of Use

Device Description: ParallelTM is a Prescription Digital Therapeutic (PDT) web application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS).

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?
65220	Mindfulness/behavioural therapy software, non-clinician-consultative	A software program intended to be used with an off-the-shelf computer/tablet/smartphone to help treat affective/mood disorders, stress, and/or other disorders related to or caused by these, by providing a patient with on-screen therapeutic exercises (e.g., mindfulness, mental imagery, cognitive behavioural therapy) often with educational information; it is not dedicated to exposure therapy. It is intended for use by a patient at home and is not based on consultation with a clinician.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
QMY	Computerized Behavioral Therapy Device For Treating Symptoms

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN200029	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: 685638e8-f631-44bf-9116-56ee90e2f899
Public Version Date: March 26, 2021
Public Version Number: 1
DI Record Publish Date: March 18, 2021