TempaDOT

Basic Information

• Brand Name: TempaDOT
• Primary DI: 00016944301059
• Version / Model: 5147
• Catalog Number: TD Bulk F
• Company Name: MEDICAL INDICATORS INC
• Labeler DUNS: 030104165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 250
• 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: a560830f-46dd-4bce-a054-aca8345366aa

Device Description

TempaDOT Bulk F Single Use Clinical 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: No
• Sterilization Prior Use: No

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
Package	20016944301053	GS1	Case	6000	In Commercial Distribution
Primary	00016944301059	GS1
Unit of Use	10016944301056	GS1

Device Sizes

Type	Value	Unit	Text
Weight	0.00046	Pound

Storage Conditions

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