FDA.reportPublic FDA data

PRIMO

Primary DI
00840216107038
Brand
PRIMO
Company
Asp Global, LLC
Model
GBARQM72BK
Device description
"BELT, QUICK CLEAN GAIT, BLACK, 72"", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2"" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS"
Published
2022-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216107038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216107038008402161070388402161070380840216107038

GMDN Terms#

Term, Definition table
TermDefinition
Gait rehabilitation system harnessA lifting device, in the form of belts and straps, which is a component of a gait rehabilitation system designed to assist a patient with a walking disability (neurogenic, muscular, or osseous in origin) regain lost motor function. The device is designed to be secured around the patient?s upper body and hips and is intended to help suspend the patient vertically over the floor or a treadmill while attached to the supporting frame of a suspension device; it may be used in conjunction with a robotic orthosis device for the training of normal gait.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216128774ASP Global / PrimoCF120B2026-09-04
00840216103696ASP MEDICALMRT1322022-08-23
00840216127869Northside HospitalNSAMK-052026-07-23
00840216129290Quest DiagnosticsQD11X16KPAP2026-07-17
00840216129801LabCorpLC13X22BIO2026-07-17
00840216108738ASP MEDICALFMT630V2020-10-21
00840216108943ASP MEDICALFMT7002020-10-21
00840216108967ASP MEDICALFMT7102020-10-21
00840216108974ASP MEDICALFMT6552020-10-21
00840216108998ASP MEDICALFMT645V2020-10-21
00840216109018ASP MEDICALFMT640V2020-10-21
00840216109025ASP MEDICALFMT635V2020-10-21
00840216110922ASP MEDICALFMT605HEART2022-02-09
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281039604Easy Mount™ Grab Bar, Modular L-Shape, 1.25x16x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039611Easy Mount™ Grab Bar, Modular L-Shape, 1.25x24x16", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281039628Easy Mount™ Grab Bar, Modular L-Shape, 1.25x30x30", KnurledHealthcraft Products Inc.IKX2026-10-08
00689281038416Easy Mount™ Grab Bar, 1.25x12", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038423Easy Mount™ Grab Bar, 1.25x18", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038430Easy Mount™ Grab Bar, 1.25x24", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281038447Easy Mount™ Grab Bar, 1.25x32", Knurled (BAG)Healthcraft Products Inc.IKX2026-10-01
00689281039253Easy Mount™ Grab Bar, 1.25x12", Matte Black (Textured)Healthcraft Products Inc.IKX2026-10-01
00689281039260Easy Mount™ Grab Bar, 1.25x24", Matte Black (Texture)Healthcraft Products Inc.IKX2026-10-01
00689281008006Easy Mount™ Grab Bar, 1.25x18", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008013Easy Mount™ Grab Bar, 1.25x24", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281008020Easy Mount™ Grab Bar, 1.25x12", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008037Easy Mount™ Grab Bar, 1.25x18", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008044Easy Mount™ Grab Bar, 1.25x24", PolishedHealthcraft Products Inc.IKX2026-09-30
00689281008082Easy Mount™ Grab Bar, 1.25x12", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008099Easy Mount™ Grab Bar, 1.25x18", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008105Easy Mount™ Grab Bar, 1.25x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008112Easy Mount™ Grab Bar, 1.25x32", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008129Easy Mount™ Grab Bar, 1.25x36", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008136Easy Mount™ Grab Bar, 1.25x42", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008143Easy Mount™ Grab Bar, 1.25x12", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008150Easy Mount™ Grab Bar, 1.25x18", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008167Easy Mount™ Grab Bar, 1.25x24", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008174Easy Mount™ Grab Bar, 1.25x32", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008181Easy Mount™ Grab Bar, 1.25x36", WhiteHealthcraft Products Inc.IKX2026-09-30
00689281008198Easy Mount™ Grab Bar, 120 degree, 1.25x24x24", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008204Easy Mount™ Grab Bar, 90 degree, 1.25x30x30", KnurledHealthcraft Products Inc.IKX2026-09-30
00689281008211Easy Mount™ Grab Bar, 1.25x12", Matte BlackHealthcraft Products Inc.IKX2026-09-30
00689281037341Easy Mount™ Grab Bar, 1.25x18", Brushed StainlessHealthcraft Products Inc.IKX2026-09-30
00689281037358Easy Mount™ Grab Bar, 1.25x24", Brushed StainlessHealthcraft Products Inc.IKX2026-09-30