FDA.reportPublic FDA data

PRIMO

Primary DI
00840216113763
Brand
PRIMO
Company
ASP GLOBAL, LLC
Model
BPW11F
Device description
Wipe Down Body Wedge Set w/ Handles - Standard, Angled - 2 each 15" Long (2 each -BPW04F)
Published
2022-03-11
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
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216113763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216113763008402161137638402161137630840216113763

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, reusableA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.

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
00860015560728Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560735Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560759Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560766Le SquishFiomet Ventures Inc.FMP2026-05-24
00860015560704Le SquishFiomet Ventures Inc.FMP2026-05-23
00860015560711Le SquishFiomet Ventures Inc.FMP2026-05-23
00860015560742Le SquishFiomet Ventures Inc.FMP2026-05-23
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