Duns Number:831375089
Device Description: PremierPro™ Air Transfer Mats are indicated for patients who are unable to transfer or tur PremierPro™ 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. Use 2 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 is l000lbs. AIR SUPPLY units may be compatible 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. May be used in situations that require transferring patients undergoing Magnetic Resonance Imaging. 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: Materials of construction for top and bottom fabrics include Nylon, PVC and Mesh. 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. Reusable models may be wiped down with disinfectant or laundered between patients. When laundering, a water and bleach mixture of 100:1 may be used. Wash the mat using hot water (s160° F/ 65° C) with a cold-water rinse. When drying, the dryer temperature should be s140° F/60° C. Drying time should be set at 60 mts. or less. The "Wrinkle Free" setting on the dryer should be set to "Off". The PremierPro Reusable Air Transfer Mat may also be air dried. The Air Transfer Mats may show signs of wear after repeated drying.
Catalog Number
3731
Brand Name
PremierPro Air Transfer Mats
Version/Model Number
3731
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
-
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
78b95fc1-f978-4951-abfa-d2d2d05aa566
Public Version Date
February 08, 2019
Public Version Number
2
DI Record Publish Date
April 10, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |