FDA.report

PRIMO

Primary DI
00840216114142
Brand
PRIMO
Company
ASP GLOBAL, LLC
Model
PPWD381445
Device description
Preventive Pad, Standard 38" Bed Width (Short Height)
Published
2022-03-18
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

Related Records

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216114142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216114142008402161141428402161141420840216114142

GMDN Terms

TermDefinition
Foot cushionA soft pillow or pad used to provide support and comfort to the user's feet, often during the treatment and/or prevention of musculoskeletal or circulatory disorders. The device may simply be used to alleviate pressure on the heels while the patient is sitting, or to slightly elevate the feet to reduce pressure and improve blood circulation in the lower extremity for the prevention of pressure sores and ulcers.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
10848530108172CPAP AccessorySUNSET HEALTHCARE SOLUTIONS, INC.FMP2026-02-02
00089904011374Action®ACTION PRODUCTS, INC.FMP2026-01-08
00089904011381Action®ACTION PRODUCTS, INC.FMP2026-01-08
00089904011398Action®ACTION PRODUCTS, INC.FMP2026-01-08
20609271989607Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989614Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989621Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989638Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
00609271989641Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989652Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989669Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989676Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989683Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989690Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989706Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989713Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989720Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989737Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989744Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989751Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
20609271989768Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-01-07
50749756401437DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01
50749756401444DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01
50749756401451DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01
50749756401468DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01
05060624126901Pediatric Face Guard Cushion - Box of 10CARE SURGICAL LIMITEDFMP2025-12-23
00810101280559garden friendsLITTLE SPARROWS TECHNOLOGIES LLCFMP2025-12-01
00810101280566garden friendsLITTLE SPARROWS TECHNOLOGIES LLCFMP2025-12-01
00810101280573garden friendsLITTLE SPARROWS TECHNOLOGIES LLCFMP2025-12-01
00810101280580garden friendsLITTLE SPARROWS TECHNOLOGIES LLCFMP2025-12-01