PremierPro - Warming Blanket, Pre Warming Gown, Size Large - SVS LLC

Duns Number:831375089

Device Description: Warming Blanket, Pre Warming Gown, Size Large plus Kit1. GENERAL DESCRIPTION · Warming Blanket, Pre Warming Gown, Size Large plus Kit1. GENERAL DESCRIPTION · PremierPro™ Multi-functional Warming Blankets 2. CONSTRUCTION · Raw material: Multi-Laminate/ Heat Sealed or Stitched Non-woven Polypropylene fabric · Yellow / Non-Breathable Air Capture Layer – Coated / Low-density polyethylene (LDPE) · White (patient facing) Layer - Perforated to enable passage of air and temperature control · Disposable / Single Patient Use · Not made with natural rubber latex. 3. MRI COMPATIBLE · Non-Metallic / Disposable Patient Warming Blankets are compatible with Magnetic Resonance Imaging equipment The Warming System is indicated for hyper or hypothermic patients or normothermic patients for who induced hyper or hypothermia or localized temperature therapy is clinically indicated. In addition, the Warming System can be used to provide patient thermal comfort when conditions exist that may cause patients to become too cold or too warm.

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More Product Details

Catalog Number

3867

Brand Name

PremierPro

Version/Model Number

3867

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

DWJ

Product Code Name

System, Thermal Regulating

Device Record Status

Public Device Record Key

dcda4764-1d45-4420-8b83-0174d0dfdf14

Public Version Date

July 05, 2021

Public Version Number

2

DI Record Publish Date

April 05, 2019

Additional Identifiers

Package DI Number

10811220032071

Quantity per Package

10

Contains DI Package

00811220032074

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1