FDA UDI In Commercial Distribution 🇺🇸 United States

PremierPro Air Transfer Mats

DI: 00818566019196 · Model: 3703 · 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
00818566019196
Version / Model
3703
Catalog Number
3703
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
3
Public Version Date
2026-03-23
Public Version Status
Update
Public Device Record Key
041d63af-2a15-4dc4-9fc1-1e886af451be

Device Description

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. 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 Disposable Models 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
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
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
No
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
Package 10818566019193
Primary 00818566019196

Customer Contacts

Phone
855-531-7699

Device Sizes

Type Value Unit Text
Length 50 Inch