FDA UDI In Commercial Distribution 🇺🇸 United States

PremierPro Air Transfer Mats

DI: 00818566019165 · Model: 3700 · PRESTIGE AMERITECH, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
PremierPro Air Transfer Mats
Primary DI
00818566019165
Version / Model
3700
Catalog Number
3700
Company Name
PRESTIGE AMERITECH, LTD.
Labeler DUNS
199692794
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-10
Public Version
2
Public Version Date
2026-03-23
Public Version Status
Update
Public Device Record Key
848bcbf6-7419-42b7-91af-9ca4626ba8b8

Device Description

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

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
Yes
MRI Safety
MR Safe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FRZ Device, Patient Transfer, Powered

GMDN Terms

Code Name
37160 Patient transfer system, powered

Identifiers

Type ID
Primary 00818566019165
Package 10818566019162

Customer Contacts

Device Sizes

Type Value Unit Text
Length 28 Inch