Thermoflect

Basic Information

• Brand Name: Thermoflect
• Primary DI: 30612899511102
• Version / Model: 5110-100
• 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: 2022-10-27
• Public Version: 2
• Public Version Date: 2023-05-05
• Public Version Status: Update
• Public Device Record Key: 28255486-f8b9-42bb-b63f-c89041032114

Device Description

THERMOFLECT CAP, UNIV, 100EA TS THERMOFLECT BOUFFANT CAP, ELASTIC, SILVER, 5/BG, 20 BG/CS

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
FME	Gown, Examination	General Hospital	880.6265	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16219	Hypothermia-prevention cap	A head covering in the form of a cap intended to be worn by a patient typically during conditions of low body temperature and/or long surgical procedures to minimize loss of body heat from the head. It typically includes a heat-reflecting inner metal surface to facilitate retention of body heat. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40612899511109	GS1	PK	5	In Commercial Distribution
Primary	30612899511102	GS1
Package	10612899511108	GS1	CA	20	In Commercial Distribution

Customer Contacts

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