AccessGUDID - DEVICE: NA (00856602005154)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: SPC-2042
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROTEUS DIGITAL HEALTH, INC.

Primary DI Number: 00856602005154
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?
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.	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: 20176e8b-01a5-4107-9bfe-8db5d1e235e5
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: May 08, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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