FDA.reportPublic FDA data

Wheelchair Anti-tipper for S3, S4

Primary DI
00616784026817
Brand
Wheelchair Anti-tipper for S3, S4
Company
Dynarex Corporation
Model
10268
Published
2019-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMRDevice, Anti-Tip, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMRDevice, Anti-Tip, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784026848PackageGS110In Commercial Distribution
00616784026817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784026848006167840268486167840268480616784026848
00616784026817006167840268176167840268170616784026817

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsibleA wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be manually propelled by the user while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. The device may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
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00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
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00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
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00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
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00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

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Primary DI, Brand, Company table
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06974231101321ValmaxSupply Line MedicalIMR2025-01-21
00841447114925ADJ REAR ANTI-TIPPER (6)INVACARE CORPORATIONIMR2024-07-25
00810113576640ViveVIVE HEALTH LLCIMR2024-07-17
00860004575641Assembly Required Distributors Inc.Assembly Required Distributors IncIMR2023-07-06
00733657224320ANTI-TIPPER W/C WITH WHEELS PAIRALIMED, INC.IMR2022-12-01
00733657224337ANTI-TIPPER W/C W/O WHEELSALIMED, INC.IMR2022-12-01
00733657286670REAR ANTI-TIPPER W/WHEELS 10/CAALIMED, INC.IMR2022-12-01
00822383157191DriveDrive Devilbiss HealthcareIMR2020-02-11
00822383977799DRIVEDrive Devilbiss HealthcareIMR2020-02-01
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00822383112848DRIVEMEDICALDrive Devilbiss HealthcareIMR2019-06-21
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00822383106922DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383106960DriveDrive Devilbiss HealthcareIMR2017-07-10
00822383106991DriveDrive Devilbiss HealthcareIMR2017-07-10
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