DermaTherapy MED Linen;FIT 42
Derma Therapy - DT-MCM-4880P-EA
Device Description
A collection of non-sterile devices including, but not limited to, a bed sheet(s), pillowcase, duvet cover and mattress cover, intended to be used to provide cover/protection to a bed and associated items. The components are treated/impregnated with an antimicrobial substance to control bacterial and fungal growth on the fabric and reduce the levels of house dust mites (HDM) and their allergen-containing faecal droppings. The device is typically made of a thin-textile or reinforced-paper material, to be used in the home or healthcare facility. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMW
Device Name: Cover, Mattress (Medical Purposes)
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 880.6190
Third Party Flag: N
Medical Specialty: HO
Device IdentifiersDevice Id: 20857268006916
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00857268006912
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 00857268006912
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