Nova

Basic Information

• Brand Name: Nova
• Primary DI: 00612899006492
• Version / Model: AW5100-300
• 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: 2021-07-07
• Public Version: 1
• Public Version Date: 2021-07-15
• Public Version Status: New
• Public Device Record Key: 6f148201-9191-484a-9188-5d07bb642f0f

Device Description

Nova Blanket, Lower Body Nova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/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: No
• 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
DWJ	System, Thermal Regulating	Cardiovascular	870.5900	2

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
Primary	00612899006492	GS1
Package	50612899006497	GS1		25	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K203085	000