FDA.reportPublic FDA data

PRIMO

Primary DI
00840216114050
Brand
PRIMO
Company
ASP GLOBAL, LLC
Model
GB72QRNRB
Device description
72" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Published
2022-04-08
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
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216114050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216114050008402161140508402161140500840216114050

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
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
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00745129278366Sigvaris DOFF N’ DONNER SET – Single UnitSIGVARIS INCIKX2026-03-11
00850015884658easycareSynchronis Medical, LLCIKX2026-02-20
00850015884764easycareSynchronis Medical, LLCIKX2026-02-20
00850015884962easycareSynchronis Medical, LLCIKX2026-02-20
00850015884986easycareSynchronis Medical, LLCIKX2026-02-20
00850063404006easycareSynchronis Medical, LLCIKX2026-02-20
00850063404020easycareSynchronis Medical, LLCIKX2026-02-20
00850063404044easycareSynchronis Medical, LLCIKX2026-02-20
00860000925303easycareSynchronis Medical, LLCIKX2026-02-20
00850063404068easycareSynchronis Medical, LLCIKX2026-02-13
00850063404082easycareSynchronis Medical, LLCIKX2026-02-13
00850063404105easycareSynchronis Medical, LLCIKX2026-02-13
00850063404129easycareSynchronis Medical, LLCIKX2026-02-13
00850063404143easycareSynchronis Medical, LLCIKX2026-02-13
00850063404167easycareSynchronis Medical, LLCIKX2026-02-13
00850063404181easycareSynchronis Medical, LLCIKX2026-02-13
10810132043007HCSConcordance Healthcare Solutions LLCIKX2026-01-23
10810132043014HCSConcordance Healthcare Solutions LLCIKX2026-01-23
00745129273859579 Melany Donning & Doffing SmallSIGVARIS INCIKX2026-01-19
00745129273866579 Melany Donning & Doffing Extra SmallSIGVARIS INCIKX2026-01-19
00745129273835579 Melany Donning & Doffing LargeSIGVARIS INCIKX2026-01-09
00745129273842579 Melany Donning & Doffing MEDIUMSIGVARIS INCIKX2026-01-09
00810178884940ViveVIVE HEALTH LLCIKX2026-01-08
00810178885015ViveVIVE HEALTH LLCIKX2026-01-08
10810178884206ViveVIVE HEALTH LLCIKX2025-12-06
00810178884582ViveVIVE HEALTH LLCIKX2025-12-05
00841027102441Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102458Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102465Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102632Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26