DEVICE: PremierPro Air Transfer Mats (00818566019240)

Device Identifier (DI) Information

PremierPro Air Transfer Mats
3722
In Commercial Distribution
3722
SVS LLC
00818566019240
GS1

1
831375089 *Terms of Use
Reusable INTENDED USE/ CONTRAINDICATIONS PrernierPro'" 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 1,000Ibs (450kg) AIR SUPPLY Air 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 USE 1. 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.
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Device Characteristics

MR Safe
No
Yes
No
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
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FDA Product Code

[?]
Product Code Product Code Name
FRZ Device, Patient Transfer, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Length: 39 Inch
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Device Record Status

ebd24981-f616-47f5-a883-209312a5f894
February 08, 2019
2
April 10, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
1-855-531-7699
info@s2s-global.com
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