FDA UDI In Commercial Distribution 🇺🇸 United States

PremierPro Air Transfer Mats

DI: 00818566019240 · Model: 3722 · SVS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
PremierPro Air Transfer Mats
Primary DI
00818566019240
Version / Model
3722
Catalog Number
3722
Company Name
SVS LLC
Labeler DUNS
831375089
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-04-10
Public Version
2
Public Version Date
2019-02-08
Public Version Status
Update
Public Device Record Key
ebd24981-f616-47f5-a883-209312a5f894

Device Description

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.

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
No
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
Primary 00818566019240

Customer Contacts

Device Sizes

Type Value Unit Text
Length 39 Inch