PremierPro Air Transfer Mats

FDA UDI

Class II (US FDA UDI)

by Svs Llc

Identity

Trade Name: PremierPro Air Transfer Mats FDA UDI
Generic Name: Patient transfer system, powered FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 3732 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 3732 FDA UDI
Primary DI / UDI-DI: 00818566019288 FDA UDI
FDA Product Code: FRZ FDA UDI
GMDN Term: Patient transfer system, powered FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.6775 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 39 Inch FDA UDI

Category: Patient transfer system, powered

PremierPro Air Transfer Mats by Svs Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Svs Llc

Sources (1)

FDA UDI 0de01c05-2a3b-4998-94ec-9844089020e3 36 fields · synced May 31, 2026