AirWedge HTPP-200

GUDID 00816299011388

HoverTech Dual Chamber Inflatable Wedge

Hovertech International

Manual patient lifting belt/harness Manual patient lifting belt/harness Manual patient lifting belt/harness

• Primary Device ID: 00816299011388
• NIH Device Record Key: 34afb934-7921-4bc9-aae0-413ed497b325
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirWedge
• Version Model Number: HTPP-200
• Catalog Number: HTPP-200
• Company DUNS: 942139841
• Company Name: Hovertech International
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)471-2776
• Email: info@hovermatt.com
• Phone: +1(800)471-2776
• Email: info@hovermatt.com
• Phone: +1(800)471-2776
• Email: info@hovermatt.com

Device Dimensions

• Width: 23 Inch
• Width: 23 Inch
• Width: 23 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816299011388 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121287

FDA Product Code

• FNG: LIFT, PATIENT, AC-POWERED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

Devices Manufactured by Hovertech International

• 00816299012729 - PROS Wedge: 2024-04-24 PROS Wedge
• 00816299012750 - PROS Tail: 2024-04-24 Wedge with Tail
• 00816299010213 - HoverMatt T-Burg: 2022-10-04 Trendelenburg Patient Stabilization & Air Transfer Mattress
• 00816299011685 - HoverMatt SPU Plus HoverCover: 2022-10-04 34" HoverMatt Plus HoverCover Kit
• 00816299011708 - HoverMatt SPU Plus HoverCover: 2022-10-04 HoverMatt SPU Plus HoverCover
• 00816299010237 - HoverSling Repositiong Sling-TVA: 2021-11-08 39" Single Patient Use Repositioning HoverSling Breathable TVA
• 00816299010244 - HoverSling Repositiong Sling-TVA: 2021-11-08 50" Single Patient Use Repositioning HoverSling Breathable TVA
• 00816299010404 - HoverJack: 2018-07-06 32" HoverJack