NIKO

Basic Information

• Brand Name: NIKO
• Primary DI: 10853512006971
• Version / Model: 8200
• Catalog Number: 8200
• Company Name: NIKOMED USA
• Labeler DUNS: 073648341
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-12-09
• Public Version: 1
• Public Version Date: 2025-12-17
• Public Version Status: New
• Public Device Record Key: 4d72347d-db89-4c4e-8180-7d5434e81498

Device Description

THERMAL RELECTORS - LARGE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15752	Infant heat shield	A protective guard intended to be used to reduce heat loss due to insensible water loss, i.e., evaporation, during the radiant warming of primarily premature infants. 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	00853512006974	GS1
Primary	10853512006971	GS1
Package	20853512006978	GS1	Box	5	In Commercial Distribution

Customer Contacts

• Phone: [phone] ext. 205
• Email: [email protected]