PremierPro Air Transfer Mats
- Primary DI
- 00818566019165
- Brand
- PremierPro Air Transfer Mats
- Company
- SVS LLC
- Model
- 3700
- Catalog number
- 3700
- 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.
- Published
- 2018-04-10
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| FRZ | Device, Patient Transfer, Powered |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| FRZ | Device, Patient Transfer, Powered | General Hospital | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10818566019162 | Package | GS1 | 10 | In Commercial Distribution |
| 00818566019165 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10818566019162 | 10818566019162 | | |
| 00818566019165 | 00818566019165 | 818566019165 | 0818566019165 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Device Sizes
| Type | Value | Unit |
|---|
| Length | 28 | Inch |
Regulatory Flags
- DUNS number
- 831375089
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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