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.
Catalog Number
3700
Brand Name
PremierPro Air Transfer Mats
Version/Model Number
3700
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRZ
Product Code Name
Device, Patient Transfer, Powered
Public Device Record Key
848bcbf6-7419-42b7-91af-9ca4626ba8b8
Public Version Date
May 11, 2018
Public Version Number
1
DI Record Publish Date
April 10, 2018
Package DI Number
10818566019162
Quantity per Package
10
Contains DI Package
00818566019165
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
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 |