DEVICE: PremierPro Air Transfer Mat (00818566019219)
Device Identifier (DI) Information
PremierPro Air Transfer Mat
3711
In Commercial Distribution
3711
SVS LLC
3711
In Commercial Distribution
3711
SVS LLC
INTENDED USE/ CONTRAINDICATIONS
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.
PRECAUTIONS & 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 l,000lbs (450kg).
AIR SUPPLY
Air 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 SAFETY
PremierPro™ 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.
CLEANING
The PremierPro™ Disposable Air Transfer Mat is not intended to be laundered and reused. Check Local, State and Federal Guidelines before disposing of this product.
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
37160 | Patient transfer system, powered |
A mains electricity (AC-powered) assembly of devices used to transfer a supine patient, typically from his/her bed or transport stretcher to an operating table or vice versa. It is usually installed in large operating room (OR) complexes and serves as a sluice providing demarkation between the OR staff and the ward staff/porters and related devices. It may be designed as a motorized belt that is wider than the length of the patient and that rotates around a moveable pick-up plate which feeds in under the patient, drawing him/her onto the belt and depositing him/her onto an adjacent surface. It is typically fully automated, requiring no human intervention other than to operate the controls.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRZ | Device, Patient Transfer, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 39 Inch |
Device Record Status
78a393b7-3514-4239-8ba9-a15d9bb0864d
February 14, 2019
2
April 10, 2018
February 14, 2019
2
April 10, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10818566019216 | 10 | 00818566019219 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-855-531-7699
udi@s2s-global.com
udi@s2s-global.com