DEVICE: PremierPro Air Transfer Mats (00818566019264)

Device Identifier (DI) Information

PremierPro Air Transfer Mats
3730
In Commercial Distribution
3730
SVS LLC
00818566019264
GS1

1
831375089 *Terms of Use
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 minutes 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.
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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: 28 Inch
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Device Record Status

4d8948d9-4cda-49a3-b440-2c71d05d2b2f
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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