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Arctic Sun® Temperature Management System, ArcticGel™ Pads

FDA UDI

Class II (US FDA UDI)

by Medivance, Inc.

Identity

Trade Name
Arctic Sun® Temperature Management System, ArcticGel™ Pads FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, reusable FDA UDI
Device Name
Arctic Sun® Temperature Management System, ArcticGel™ Pads FDA UDI
Model / Reference
31705 FDA UDI
Description
Arctic Sun® Temperature Management System, ArcticGel™ Pads FDA UDI

Identifiers

Catalog Number
31705 FDA UDI
Primary DI / UDI-DI
00801741080067 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: External circulating-fluid core temperature regulation system pad, reusable

Arctic Sun® Temperature Management System, ArcticGel™ Pads by Medivance, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system pad, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medivance, Inc.

Sources (1)

  • FDA UDI bc0082bc-d91f-4d3b-8b13-2750ed1e948a 35 fields · synced Jun 6, 2026