AccessGUDID - DEVICE: Proteus Digital Health Feedback System (00856602005215)

GUDID

Device Identifier (DI) Information

Brand Name: Proteus Digital Health Feedback System
Version or Model: SPC-2329
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROTEUS DIGITAL HEALTH, INC.

Primary DI Number: 00856602005215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149825791 *Terms of Use

Device Description: No description.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62237	Medication adherence telemetric monitoring system, post-ingestion	An assembly of electronic devices intended to help assess the medication adherence of a patient who is self-managing oral medication by monitoring medication ingestion. It consists of a transmitter(s) intended to be swallowed by the patient with their medication, a patient worn transceiver with an electrode, and dedicated software. The transmitter activates upon wetting in the stomach, and transmits an electrical signal to the patient-worn transceiver, which records an event to confirm medication has been taken. The transceiver wirelessly communicates with an off-the-shelf device with the software installed, and may also record additional relevant data (e.g., heart rate, body angle).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OZW	Ingestible event marker
DXH	TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150494	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: 17a82744-d898-42eb-a873-7f9d65d0e577
Public Version Date: August 02, 2018
Public Version Number: 1
DI Record Publish Date: July 02, 2018