DabirAir Microclimate

Basic Information

• Brand Name: DabirAir Microclimate
• Primary DI: 00851343006163
• Version / Model: MC-3S3584-01
• Company Name: DABIR SURFACES, INC.
• Labeler DUNS: 079374086
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 3
• Public Version Date: 2019-05-20
• Public Version Status: Update
• Public Device Record Key: fa1ef033-a326-40c7-9c85-a40078c77b8f

Device Description

MedSurg Microclimate Overlay (33" Wide) - CE

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: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	880.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41900	Alternating-pressure bed mattress overlay, reusable	A pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an 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. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851343006163	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	84	Inch
Width	35	Inch
Device Size Text, specify			Tubing: 1' Length

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 40 – 60 Degrees Celsius