FDA.reportPublic FDA data

Blueline

Primary DI
00199536930223
Brand
Blueline
Company
Transparent Supply Solutions Ltd.
Model
7815
Device description
"Walker Wheel, Fixed, 5"""
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
50199536930228PackageGS160In Commercial Distribution
00199536930223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5019953693022850199536930228
00199536930223001995369302231995369302230199536930223

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.

Regulatory Flags#

DUNS number
119522714
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199536905610Blueline40612026-08-07
00199536905627Blueline40622026-08-07
00199536905634Blueline40632026-08-07
00199536905641Blueline40642026-08-07
00199536905658Blueline40652026-08-07
00199536924000BluelineX84152026-08-07
00199536924024BluelineX84252026-08-07
00199536924031BluelineX84352026-08-07
00199536924055BluelineX8435R2026-08-07
00199536925007BluelineB8310B2026-08-07
00199536925014BluelineB8310W2026-08-07
00199536925021BluelineB8320B2026-08-07
00199536925038BluelineB8320G2026-08-07
00199536925045BluelineB8320W2026-08-07
00199536925052Blueline8321B2026-08-07
00199536925069Blueline8322B2026-08-07
00199536925076Blueline8322W2026-08-07
00199536925083Blueline8324B2026-08-07
00199536925090Blueline8324G2026-08-07
00199536925106Blueline8326B2026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"Dynarex CorporationITJ2026-08-03
08054040402548GRILLOORMESA SRLITJ2026-08-01
00860001638721PerfectFit Standard RollatorCarrier Medical LLCITJ2026-07-13
00860001638783PerfectFit Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860001638790Phantom Knee WalkerCarrier Medical LLCITJ2026-07-13
00860014392702ICON Heavy Duty RollatorCarrier Medical LLCITJ2026-07-13
00860014392719ICON Standard RollatorCarrier Medical LLCITJ2026-07-13
00860014392726AirLite Standard RollatorCarrier Medical LLCITJ2026-07-13
04719876190253TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.ITJ2026-07-08
00841447116547Invacare Essentials RollatorINVACARE CORPORATIONITJ2026-07-01
00194346283439EquateDrive Devilbiss HealthcareITJ2026-06-10
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
00057475820213BIOS LivingThermor LtdITJ2026-01-19
08054040402432GRILLOORMESA SRLITJ2025-09-15
08054040402449GRILLOORMESA SRLITJ2025-09-15