NexTemp

Basic Information

• Brand Name: NexTemp
• Primary DI: 00016944401452
• Version / Model: 8500-12
• Catalog Number: NXT GO F
• Company Name: MEDICAL INDICATORS INC
• Labeler DUNS: 030104165
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2024-08-29
• Public Version: 1
• Public Version Date: 2024-09-06
• Public Version Status: New
• Public Device Record Key: 86232c24-9457-4078-8bca-5a2db5167665

Device Description

NexTemp GO F single-use clinical thermometer DTC 12pk

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: Yes
• 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
Unit of Use	10016944401435	GS1
Primary	00016944401452	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Weight	0.23	Gram

Storage Conditions

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