Device
Digital Oral/Rectal Thermometer 10s response time, 1/bx 10bx/ct 30ct/cs
Manufacturer
Twin Med, LLC
Twin Med, LLC
Model: PCDT60
Catalog: PCDT60
DI: 10840330706558
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Digital Oral/Rectal Thermometer 10s response time, 1/bx 10bx/ct 30ct/cs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
32d08878-19bf-4c45-86ba-91307b86dbc0
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
30840330706552
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840330706558
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840330706558
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Case
Item #3 - Device ID:
50840330706556
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
30
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
30840330706552
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 14035
Name: Intermittent electronic patient thermometer
Definition:
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.
FDA Product Codes
SDV
Clinical Electronic Thermometer
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Store between -4 and 131 F, 15 - 95% Humidity. Keep dry and away from sunlight.
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value:
-4
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value:
131
Item #2 - Storage Handling Type:
Storage Environment Temperature