Greenline Cruiser Wheelchair 16" with Foot Rest

GUDID 00840117334359

DYNAREX CORPORATION

Attendant-only-propelled wheelchair, non-bariatric
Primary Device ID00840117334359
NIH Device Record Key94c84893-3f69-46ff-b0f4-9d3c5417990d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGreenline Cruiser Wheelchair 16" with Foot Rest
Version Model Number10283-FR
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 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
GS100840117334359 [Primary]

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 Date2024-08-01
Device Publish Date2024-07-24

Devices Manufactured by DYNAREX CORPORATION

00840117334342 - Resp-O2 Oxygen Tubing 5.4mm Step Down Adaptor2024-09-04
08401173315564 - DynaSafety Sheer Plastic Adhesive Bandages,Sterile with Non-Stick Pad2024-08-06 2" x 3"
08401173315700 - DynaSafety Sheer Plastic Adhesive Bandages,Sterile with Non-Stick Pad 2024-08-06 2" x 3"
08401173284570 - DynaCare Tampons Regular Cardboard Applicator 2024-08-02 Not-Sterile
00840117338067 - Resp-O2 M24 Oxygen E-Cylinder 4.6 L with CGA870 Toggle Valve 2024-08-02
00840117338074 - Resp-O2 M15 Oxygen Jumbo D-Cylinder 2.9 L with CGA870 Toggle Valve 2024-08-02
00840117338135 - Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve 2024-08-02 Standard: Dot -3AL, Nominal Working Pressure; 139 (BAR), Hydraulic Test Pressure: 232 (BAR), Material: Aluminum alloy 6061, Actu
00840117334359 - Greenline Cruiser Wheelchair 16" with Foot Rest 2024-08-01
00840117334359 - Greenline Cruiser Wheelchair 16" with Foot Rest 2024-08-01

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