Nova

GUDID 00612899006492

Nova Blanket, Lower Body Nova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/CS

Encompass Group, L.L.C.

Hypothermia-prevention whole-body suit

• Primary Device ID: 00612899006492
• NIH Device Record Key: 6f148201-9191-484a-9188-5d07bb642f0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nova
• Version Model Number: AW5100-300
• Company DUNS: 121788819
• Company Name: Encompass Group, L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET
• Phone: 800-284-4540
• Email: COMPLIANCE@ENCOMPASSGROUP.NET

Device Identifiers

Device Issuing Agency	Device ID
GS1	00612899006492 [Primary]
GS1	50612899006497 [Package]; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203085

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-15
• Device Publish Date: 2021-07-07

On-Brand Devices [Nova]

• 00612899006492: Nova Blanket, Lower Body Nova Blanket, Lower Body, 30"W x 51"L, IND PKG, 25 EA/CS
• 50612899006480: NOVA BLANKET, UPPER BODY NOVA BLANKET, UPPER BODY,70"W X 25"L,IND P
• 00612899006478: NOVA SMART CABLE NOVA SMART CABLE, 10', 1 EA
• 00612899006430: NOVA CONTROLLER, 115V NOVA PATIENT WARMING CONTROL UNIT, 115V, 1EA