Bariatric Reclining Wheelchair 26" with Elevating Leg Rest

GUDID 00840117322684

DYNAREX CORPORATION

Push-rim manual wheelchair, bariatric
Primary Device ID00840117322684
NIH Device Record Keyfd5126ad-749d-4af5-88ec-6371df0789ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameBariatric Reclining Wheelchair 26" with Elevating Leg Rest
Version Model Number15015-26DELR
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
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
GS100840117322684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IORWheelchair, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-16
Device Publish Date2024-05-08

Devices Manufactured by DYNAREX CORPORATION

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00840117312920 - Resp-O2 Endotracheal Tube Cuffed, 4.5 mm 2024-11-01 Sterile-EO
00840117317475 - Resp-O2 Endotracheal Tube Cuffed, 5.0 mm 2024-11-01 Sterile-EO
00840117312968 - Resp-O2 Endotracheal Tube Cuffed, 5.5 mm 2024-11-01 Sterile-Eo
00840117312982 - Resp-O2 Endotracheal Tube Cuffed, 6.0 mm 2024-11-01 Sterile-Eo
00840117313002 - Resp-O2 Endotracheal Tube Cuffed, 6.5 mm2024-11-01 Sterile-Eo
00840117313026 - Resp-O2 Endotracheal Tube Cuffed, 7.0 mm 2024-11-01 Sterile-Eo

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