Duns Number:831375089
Device Description: ReusableINTENDED USE/ CONTRAINDICATIONSPrernierPro'" Air Transfer Mats are indicated for p ReusableINTENDED USE/ CONTRAINDICATIONSPrernierPro'" 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 patientPRECAUTIONS & WARNINGS• Use 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 1,000Ibs (450kg)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.INSTRUCTIONS FOR USE1. Transfer surfaces should be close together and equal height or a slightly lower destination surface.2. Air inlet pockets are located at the foot end of pad. Locate and insert air supply hose.3. Avoid having obstructions in path of transfer including lines and hoses 4. Hold onto handles during inflation.5. Move patient in a diagonal direction. head or feet end first until patient reaches destination and is centered.6. Raise side rails, disconnect t air hose and undo safety straps.7. Use appropriate turning and rolling technique to remove transfer mat from underneath patient.
Catalog Number
3721
Brand Name
PremierPro Air Transfer Mats
Version/Model Number
3721
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
a1099ea3-8a54-417f-9714-4976c53b99dc
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 |