AirWedge

Basic Information

• Brand Name: AirWedge
• Primary DI: 00816299011388
• Version / Model: HTPP-200
• Catalog Number: HTPP-200
• Company Name: Hovertech International
• Labeler DUNS: 942139841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 34afb934-7921-4bc9-aae0-413ed497b325

Device Description

HoverTech Dual Chamber Inflatable Wedge

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FNG	LIFT, PATIENT, AC-POWERED	General Hospital	880.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40538	Manual patient lifting belt/harness	A device used to assist healthcare professionals or attending persons to physically move and lift a patient or a person with a disability (e.g., from the floor to a bed). The device is typically made strong textile materials (e.g., nylon or canvas) consisting of belts/harnesses. The device will typically require two persons to safely perform the lift. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816299011388	GS1

Customer Contacts

• Phone: [phone] ext. 103
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121287	000

Device Sizes

Type	Value	Unit	Text
Width	23	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit