PremierPro Air Transfer Mat - INTENDED USE/ CONTRAINDICATIONSPremierPro™ Air - SVS LLC

Duns Number:831375089

Device Description: INTENDED USE/ CONTRAINDICATIONSPremierPro™ Air Transfer Mats are indicated for patients:Wh INTENDED USE/ CONTRAINDICATIONSPremierPro™ Air Transfer Mats are indicated for patients:Who are unable to transfer or turn by their own effort, both assisted and unassisted.Whose size and weight present possible risks to caregivers involved in the transfer of the patient.PRECAUTIONS & WARNINGSUse two or more caregivers during patient transfers.Do not use transfer mat until user manual is reviewed.Do not leave patient unattended on inflated transfer mat.Do not attempt to move patient on uninflated transfer mat.The maximum safe working load for all PremierPro™ Air Transfer Mats is l,000lbs (450kg).AIR SUPPLYAir supply units may be compatible with Premier™ 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.CLEANINGThe 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

3710

Brand Name

PremierPro Air Transfer Mat

Version/Model Number

3710

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

FRZ

Product Code Name

Device, Patient Transfer, Powered

Device Record Status

Public Device Record Key

0030510c-7189-4998-8924-234fb1dca8f7

Public Version Date

February 08, 2019

Public Version Number

2

DI Record Publish Date

April 10, 2018

Additional Identifiers

Package DI Number

10818566019209

Quantity per Package

10

Contains DI Package

00818566019202

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