ThermalX

Basic Information

• Brand Name: ThermalX
• Primary DI: 10615089702102
• Version / Model: 951
• Catalog Number: 7021-0001
• Company Name: ADROIT MEDICAL SYSTEMS, INC.
• Labeler DUNS: 795104769
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-04
• Public Version: 1
• Public Version Date: 2019-10-14
• Public Version Status: New
• Public Device Record Key: dfe383a0-8af8-469f-8224-d60e3a0bebda

Device Description

Kit: Medium Blanket; Adult Cap; 2 legs

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FME	Gown, Examination	General Hospital	880.6265	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35092	Patient gown, single-use	A non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20615089702109	GS1	Carton	20	In Commercial Distribution
Primary	10615089702102	GS1