FDA.reportPublic FDA data

Knee Pillow

Primary DI
00810006680935
Brand
Knee Pillow
Company
PRIMO INC
Model
KP01
Catalog number
KP01
Device description
Knee Pillow - Contoured Suede
Published
2019-02-20
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
true

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
00810006680935PackageGS112In Commercial Distribution
00810006680546PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006680935008100066809358100066809350810006680935
00810006680546008100066805468100066805460810006680546

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
958758146
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
10810006683513Economy Foam Heel ProtectorHP301HP3012021-07-26
10810006683520AirFloat Static Air Seat CushionAF1717AF17172021-07-26
10810006683537AirFloat Static Air Seat CushionAF1717PAF1717P2021-07-26
10810006683742Wipe Down Body Wedge Set BPW10FBPW10F2021-07-26
10810006683759Wipe Down Body Wedge Set BPW11FBPW11F2021-07-26
10810006683780Glide & Guide Turn System KitGGTS02GGTS022021-07-26
10810006683797Glide & Guide Turn System KitGGTS02BGGTS02B2021-07-26
10810006683803Glide & Guide Turn System KitGGTS01GGTS012021-07-26
10810006683810Glide & Guide Turn System KitGGTS01BGGTS01B2021-07-26
10810006683827Glide & Guide Turn System Kit EconomyGGTS03GGTS032021-07-26
10810006683834Glide & Guide Turn System Kit EconomyGGTS03BGGTS03B2021-07-26
10810006683841Wipe Down Body Wedge Set, RoundedBPW10RBPW10R2021-07-26
10810006683858Wipe Down Body Wedge Set, RoundedBPW11RBPW11R2021-07-26
10810006684053Glide & Guide Turn System KitGGTS05GGTS052021-07-26
10810006684060Glide & Guide Turn System KitGGTS05BGGTS05B2021-07-26
10810006684077Glide & Guide Turn System KitGGTS06BGGTS06B2021-07-26
10810006684084Glide & Guide Turn System KitGGTS06GGTS062021-07-26
10810006684091Glide & Guide Turn System Kit EconomyGGTS04GGTS042021-07-26
10810006684107Glide & Guide Turn System Kit EconomyGGTS04BGGTS04B2021-07-26
10810006684114AirFloat Static Air Seat CushionAF1919PAF1919P2021-07-26

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