FDA.reportPublic FDA data

Bariatric HD Rollator

Primary DI
00840117327610
Brand
Bariatric HD Rollator
Company
DYNAREX CORPORATION
Model
10217
Device description
Weight Capacity- 700lb
Published
2023-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117327610PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117327610008401173276108401173276100840117327610

GMDN Terms#

Term, Definition table
TermDefinition
Handgrip disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975960550749noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-05-25
06975960550701noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-03-24
00810178887392Vive MobilityVIVE HEALTH LLCITJ2026-02-18
00860014768644RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00860014768651RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00810178883882Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178883899Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885206Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885497Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885503Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885510Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887064Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887071Vive MobilityVIVE HEALTH LLCITJ2026-02-03
04895262504016HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-01-26
00057475820213BIOS LivingThermor LtdITJ2026-01-19
06975960550602noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-15
06975185620166BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDITJ2026-01-07
06975960551470VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06975960551487VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06979196001167RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001174RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001181RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001198RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001204RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001211RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001228RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001235RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001242RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001259RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06975960551463VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2025-12-03