NexTemp

Basic Information

• Brand Name: NexTemp
• Primary DI: 00016944401100
• Version / Model: 8200
• Catalog Number: NXT Ultra C
• 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: 4b80206e-1c4a-46f1-bdb2-fd346bb489c7

Device Description

NexTemp Ultra C Single-use Clinical Thermometer

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
33618	Liquid-crystal patient thermometer, single-use	A device designed to measure a patient's skin, oral, rectal, or axillary (armpit) body temperature. It uses liquid-crystal sensors (usually formed from esters of cholesterol) that are sealed in a plastic band and appear to change colour at indicated temperatures. The device may be used in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20016944401104	GS1	Case	2000	In Commercial Distribution
Primary	00016944401100	GS1
Unit of Use	10016944401107	GS1

Device Sizes

Type	Value	Unit	Text
Weight	0.00150	Pound

Storage Conditions

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