TempaDOT

Basic Information

• Brand Name: TempaDOT
• Primary DI: 00016944301042
• Version / Model: 5125
• Catalog Number: TD Sterile F
• Company Name: MEDICAL INDICATORS INC
• Labeler DUNS: 030104165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-05-29
• Public Version: 2
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: ec2e02e9-895b-47b2-93e3-96a4576536e5

Device Description

TempaDOT F Sterile Single use Thermometer

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQZ	Thermometer, Clinical Color Change	General Hospital	880.2900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35899	Colour-indication patient thermometer	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. The device records body temperature using heat sensitive chemical cells (dots) which are sealed at the end of a plastic or metal strip. Body heat causes a colour change in the heat sensitive chemicals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10016944301025	GS1
Primary	00016944301042	GS1

Device Sizes

Type	Value	Unit	Text
Weight	0.00143	Pound

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 30 Degrees Celsius