DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"

GUDID 00840117321953

Weight Capacity: 350 LB.

Dynarex Corporation

Lumbar cushion
Primary Device ID00840117321953
NIH Device Record Key81acc51f-103e-431b-923c-59ee1fc25d14
Commercial Distribution StatusIn Commercial Distribution
Brand NameDMECare Solutions Ever-Soft Lumbar Support Cushion, 22"
Version Model Number13042-22
Company DUNS008124539
Company NameDynarex Corporation
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117321946 [Package]
Package: Shipper [4 Units]
In Commercial Distribution
GS100840117321953 [Primary]

FDA Product Code

IMPCushion, Wheelchair

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-01
Device Publish Date2025-08-22

Devices Manufactured by Dynarex Corporation

00840117321915 - DMECare Solutions Ever-Soft Lumbar Support Cushion,18"2025-09-01 Weight Capacity: 350 LB.
00840117321939 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 20" 2025-09-01 Weight Capacity: 350 LB.
00840117321953 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"2025-09-01Weight Capacity: 350 LB.
00840117321953 - DMECare Solutions Ever-Soft Lumbar Support Cushion, 22"2025-09-01 Weight Capacity: 350 LB.
00616784470429 - IV Start Kit with Nitrile Gloves, Sterile-EO 2025-08-27
00616784704111 - IV Adminstration Set, 10 mL, Non-Toxic 2025-08-11 Sterile-EO
00616784704210 - IV Administration Sets, 10 mL, Non-Toxic 2025-08-11 Sterile-EO
00616784704418 - IV Administration Set, 20 mL, Non-Toxic2025-08-11 Sterile-EO
00616784304113 - Dmecare Solutions Solid Seat Insert2025-07-17 Solid Seat Insert 16"x16". Weight Capacity: 300 LB.

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