Thermoflect

Basic Information

• Brand Name: Thermoflect
• Primary DI: 30612899004277
• Version / Model: 5140-600
• Company Name: Encompass Group, L.L.C.
• Labeler DUNS: 121788819
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-01
• Public Version: 2
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 1e7483b8-3a48-4725-a36c-cb43bb6be5dc

Device Description

THERMOFLECT JACKET, 2X, 25EA TS THERMOFLECT JACKET, KNIT COLLAR/CUFFS, SILVER, 5 BG/CS NW

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: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62340	Hypothermia-prevention whole-body suit	A full-body overall intended to be worn by a patient in a clinical setting to minimize loss of body heat when the patient experiences low body temperature and/or is under at-risk conditions for low body temperature (e.g., long surgical procedures). It is typically a multilayer or multi-laminate suit made of synthetic materials including a layer with heat-insulating properties to facilitate retention of body heat. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40612899004274	GS1	PK	5	In Commercial Distribution
Primary	30612899004277	GS1
Package	10612899004273	GS1	CA	5	In Commercial Distribution

Customer Contacts

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