Device
The wearable sensor in the Otsuka Digital Feedback Device is a body-worn sensor that consists of a single-use patch known as the D-Tect wearable sensor or D-Tect Patch. The D-Tect...
Manufacturer
Otsuka America Pharmaceutical Inc
Otsuka America Pharmaceutical Inc
Model: Patch
Catalog: SPC-2731
DI: 00857335005114
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
The wearable sensor in the Otsuka Digital Feedback Device is a body-worn sensor that consists of a single-use patch known as the D-Tect wearable sensor or D-Tect Patch. The D-Tect Patch collects physiological and behavioral metrics such as heart rate, activity, body angle, and time stamped patient-logged events, including events signaled by the co-incidence with, or co-ingestion with, the ingestible sensor accessory. Note: While the device includes automated heart rate (HR) measurement, it does not provide an ECG waveform recording for display or analysis. The device is not intended to diagnose heart-related conditions and does not include alarms. HR measurement is not intended to be used in alarm system. HR data may not be accurate for patients with pacemakers.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2981eaf7-9914-45ad-8a00-76c6186e9818
Distribution Status:
In Commercial Distribution
DUNS Number:
008314390
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
Yes
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00857335005114
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62385
Name: Gastrointestinal telemetric monitoring system capsule, ingestible
Definition:
A battery-powered (conventional or physiologic), electronic component of a gastrointestinal telemetric monitoring system designed to be swallowed by a patient for the wireless signal transmission of one or more gastrointestinal parameters (i.e., pH, pressure, temperature) or events (e.g., gastrointestinal bleeding). The capsule contains a sensor(s) and the telemetric signals it produces are detected by an extracorporeal (e.g., patient-worn) receiver or transceiver; information is displayed by the receiver, or transmitted by the transceiver to a computer with software for display. The capsule is excreted from the gut. This is a single-use device.
FDA Product Codes
OZW
Ingestible Event Marker
Device Sizes
Item #1 - Size - @attributes - Unit:
Millimeter
Item #1 - Size - @attributes - Value:
113.2
Item #1 - Size Type:
Length
Item #2 - Size - @attributes - Unit:
Millimeter
Item #2 - Size - @attributes - Value:
45.2
Item #2 - Size Type:
Width
Item #3 - Size - @attributes - Unit:
Millimeter
Item #3 - Size - @attributes - Value:
6.9
Item #3 - Size Type:
Height
Item #4 - Size - @attributes - Unit:
Square centimeter
Item #4 - Size - @attributes - Value:
32.1
Item #4 - Size Type:
Area/Surface Area
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
5
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
40
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
5
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
27
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
15
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
93
Item #3 - Storage Handling Type:
Storage Environment Humidity
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
15
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
93
Item #4 - Storage Handling Type:
Handling Environment Humidity
Item #5 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #5 - Storage Handling Low - @attributes - Value:
70
Item #5 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #5 - Storage Handling High - @attributes - Value:
106
Item #5 - Storage Handling Type:
Handling Environment Atmospheric Pressure