IsoAir - 2941
Device Description
An assembly of devices consisting of an alternating-pressure bed mattress overlay and a dedicated pump, which also functions as the control unit, designed to actively alternate a bed occupant's bed-contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat.
Environmental Conditions
- 106.00
- 70.00
- 75.00
- 30.00
- 40.00
- 10.00
- 106.00
- 50.00
- 95.00
- 10.00
- 60.00
- 40.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FNM
Device Name: Mattress, Air Flotation, Alternating Pressure
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.5550
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 07613327503999
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A