PremierPro Air Transfer Mats - AIR SUPPLYAir supply units may be compatible with - SVS LLC

Duns Number:831375089

Device Description: AIR SUPPLYAir supply units may be compatible with PremierPro™ Air Transfer Mats if th AIR SUPPLYAir supply units may be compatible with PremierPro™ Air Transfer Mats if they provide 3 psi pressure and 80 cfm capacity. The hose used may be a standard 1.75" diameter hose that may be secured with a snap fastener or hook & loop fastener. Always refer the air supply unit's operating instructions, observing all precautions and warnings. All safety guidelines within the air supply unit's operating instructions should be followed.MRI SAFETYPremierPro™ Air Transfer Mats may be used in situations that require transferring patients undergoing Magnetic Resonance Imaging (MRI). PremierPro™ Air Transfer Mats have been evaluated for use with MRI and have been determined to be safe for use. This conclusion is based on the following factors:Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh.Safety strap buckles are constructed from Polypropylene.Air supply fasteners are manufactured from non-ferrous metal.Air supply fasteners are not in the radio frequency field or the field of imaging and will not cause artifacts.Evaluation of these factors indicates PremierPro™ Air Transfer Mats are safe when used with patients undergoing MRI.CLEANINGDisposable ModelsThe PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.

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More Product Details

Catalog Number

3703

Brand Name

PremierPro Air Transfer Mats

Version/Model Number

3703

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

-

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

FRZ

Product Code Name

Device, Patient Transfer, Powered

Device Record Status

Public Device Record Key

041d63af-2a15-4dc4-9fc1-1e886af451be

Public Version Date

February 08, 2019

Public Version Number

2

DI Record Publish Date

April 10, 2018

Additional Identifiers

Package DI Number

10818566019193

Quantity per Package

5

Contains DI Package

00818566019196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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