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.
Catalog Number
-
Brand Name
PremierPro Air Trasnsfer
Version/Model Number
3702
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)
-
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
3c2cb501-2e88-40ef-aa64-eb723c1421ef
Public Version Date
February 06, 2019
Public Version Number
2
DI Record Publish Date
April 10, 2018
Package DI Number
10818566019186
Quantity per Package
5
Contains DI Package
00818566019189
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 |