EasyBoost SPU Zipper Sheet with Side Handles

GUDID 00860004936879

Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108"

Seneca Devices, Inc.

Patient transfer/turning sheet, single-use
Primary Device ID00860004936879
NIH Device Record Keyebe0487e-fc37-4cf3-b608-7620c4c3e2cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasyBoost SPU Zipper Sheet with Side Handles
Version Model NumberESB-DIS-2027
Company DUNS117658378
Company NameSeneca Devices, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860004936879 [Primary]
GS110860004936876 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

FMRDevice, Transfer, Patient, Manual

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-25
Device Publish Date2024-10-17

Devices Manufactured by Seneca Devices, Inc.

00860004936824 - EasyBoost 4002024-10-25 Air blower unit (with hook) for use with EasyBoost Cushion, for safe working load up to 400 lbs
00860004936879 - EasyBoost SPU Zipper Sheet with Side Handles2024-10-25Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108"
00860004936879 - EasyBoost SPU Zipper Sheet with Side Handles2024-10-25 Case of 12 Sheets with zipper and side handles for in-bed repositioning, Polyester fabric, 66" x 108"
00860004936831 - EasyBoost2024-08-08 EasyBoost repositioning system compatible with HoverMatt.
00860004936855 - EasyBoost2024-07-17 EasyBoost Repositioning System V1 Compatible with EasyShift Zipper Sheet
00860004936817 - EasyShift2024-01-22 EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet
00860004936848 - EasyShift2024-01-22 EasyShift Repositioning System V3 for 36-inch wide mattress
10860004936869 - EasyShift Sheet2024-01-22 EasyShift SPU Zipper Sheet

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