NA

Basic Information

• Brand Name: NA
• Primary DI: 10856602005106
• Version / Model: SPC-1330.B55
• Company Name: PROTEUS DIGITAL HEALTH, INC.
• Labeler DUNS: 149825791
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: bd850b8c-818f-4a19-8c0b-d530ad7f3c76

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OZW	Ingestible event marker	General Hospital	880.6305	2
DXH	TRANSMITTERS AND RECEIVERS, ELECTROCARDIOGRAPH, TELEPHONE	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62238	Medication adherence telemetric monitoring system ingestible transmitter	A non-sterile component of a medication adherence telemetric monitoring system intended to be ingested simultaneously with medication to transmit an electrical signal across tissues to a patient worn transceiver indicating that the medication has been taken. It is typically a transmitter housed in a placebo tablet which activates upon wetting (i.e., in the stomach). It does not include any active pharmaceuticals and is not intended for measuring physiological parameters.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10856602005106	GS1
Unit of Use	00856602005109	GS1

Premarket Submissions

Submission Number	Supplement Number
K133263	000
K150494	000