FDA.reportPublic FDA data

BRYDAN MEDICAL

Primary DI
00863574000476
Brand
BRYDAN MEDICAL
Company
BRYDAN MEDICAL HOLDINGS
Model
99999
Device description
"Alum Transport W/C 18"" seat width, green uph. "
Published
2018-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973418000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973418000UNIVERSAL/1000 SERIES(101S101SDU1100)/ROLLS 2000(2000E)/TRANSPORT(M4)Assembly Required Dist., Inc.1997-10-09IOR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863574000476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863574000476008635740004768635740004760863574000476

GMDN Terms#

Term, Definition table
TermDefinition
Transport wheelchair, collapsibleA wheeled personal mobility device designed for transporting persons (not bariatric) over a short distance and generally limited to indoor use or use outdoors over smooth paved surfaces. It has small wheels that the occupant cannot use for propulsion and incorporates a simple seat-support system for a person with a disability or a person without the full capacity to walk. It will also include footrests to keep the occupant's feet raised from the ground. It is typically used in hospitals, institutions, airports, and railway stations. Also known as a transportation chair or transit wheelchair, it may be disassembled or folded for transport.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078612438
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853301008257Brydan Medical900792024-10-15
00853301008264Brydan Medical900942024-10-15
00853301008271Brydan Medical900532024-10-15
00853301008288Brydan Medical900472024-10-15
00853301008295Brydan Medical900862024-10-15
00853301008448Brydan Medical125252024-10-15
00853301008028BRYDAN MEDICAL116292018-01-03
00853301008035BRYDAN MEDICAL115272018-01-03
00863574000445BRYDAN MEDICAL123052017-12-29
00853301008431BRYDAN MEDICAL900512018-01-03
00863574000452BRYDAN MEDICAL122042017-12-29
00853301008011BRYDAN MEDICAL110842017-12-30
00853301008042BRYDAN MEDICAL119452018-01-03
00853301008059BRYDAN MEDICAL118992018-01-03
00853301008066BRYDAN MEDICAL118772018-01-03
00853301008073BRYDAN MEDICAL110972018-01-03
00853301008080BRYDAN MEDICAL124322018-01-03
00853301008097BRYDAN MEDICAL900662018-01-03
00863574000438BRYDAN MEDICAL115072018-01-03
00863574000469BRYDAN MEDICAL113672017-12-30

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Primary DI, Brand, Company table
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00810178885961Vive MobilityVIVE HEALTH LLCIOR2026-04-26
00810178885978Vive MobilityVIVE HEALTH LLCIOR2026-04-26
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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