FDA.reportPublic FDA data

PERFORMANCE HEALTH

Primary DI
00840216115941
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
2092
Device description
Jobst Stocking Donner
Published
2022-08-09
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
ILDAdaptor, Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILDAdaptor, DressingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216115941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216115941008402161159418402161159410840216115941

GMDN Terms#

Term, Definition table
TermDefinition
Assistive sock/pantyhose dressing deviceA device designed to assist a person with a disability to put on and take off their socks, stockings, and tights (pantyhose).

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
true
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
05050962001534EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962023048LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962057791SOXONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962080065LEG-UPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110168REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962110175REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146372REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962146389REACHER THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156210REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156227REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156234REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156241REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156258REACHERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962156265SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962161269SHOE HELPERTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962164192EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171152HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962171169HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177895HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962177918HANDI GRIP THE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962203983ARTHRI GRIPTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
05050962355002EZY-ONTHE HELPING HAND COMPANY (LEDBURY) LIMITEDILD2024-02-02
30023601042256CarexCOMPASS HEALTH BRANDS CORP.ILD2023-09-29
00840252902925Cushion GripTherafin CorporationILD2023-07-06
00840252902949Cushion GripTherafin CorporationILD2023-07-06
00840252902963Cushion GripTherafin CorporationILD2023-07-06
00840252903076EZ SliderTherafin CorporationILD2023-07-06
00840252903090EZ SliderTherafin CorporationILD2023-07-06
00840252903113EZ SliderTherafin CorporationILD2023-07-06
00840252903151EZ SliderTherafin CorporationILD2023-07-06