SizeWise Air Supply SW400AIR

GUDID 00816299011265

1100W SizeWise Air Supply

Hovertech International

Medical device air compressor
Primary Device ID00816299011265
NIH Device Record Key0831af48-13d2-49de-b323-3449acabacf7
Commercial Distribution StatusIn Commercial Distribution
Brand NameSizeWise Air Supply
Version Model NumberSW400AIR
Catalog NumberSW400AIR
Company DUNS942139841
Company NameHovertech International
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)471-2776
Emailinfo@hovermatt.com
Phone+1(800)471-2776
Emailinfo@hovermatt.com
Phone+1(800)471-2776
Emailinfo@hovermatt.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100816299011265 [Primary]

FDA Product Code

FNGLIFT, PATIENT, AC-POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-07-30

Devices Manufactured by Hovertech International

00816299011647 - Q2 Roller Lateral Turning Device2024-09-05 Q2Roller w/ 5 pack of chux
00816299011586 - Q2Roller® Lateral Turning Device2024-08-30 Q2Roller Lateral Turning Device
00816299012729 - PROS Wedge2024-04-24 PROS Wedge
00816299012750 - PROS Tail2024-04-24 Wedge with Tail
00816299010213 - HoverMatt T-Burg2022-10-04 Trendelenburg Patient Stabilization & Air Transfer Mattress
00816299011685 - HoverMatt SPU Plus HoverCover2022-10-04 34" HoverMatt Plus HoverCover Kit
00816299011708 - HoverMatt SPU Plus HoverCover2022-10-04 HoverMatt SPU Plus HoverCover
00816299010237 - HoverSling Repositiong Sling-TVA2021-11-08 39" Single Patient Use Repositioning HoverSling Breathable TVA

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.