FDA.reportPublic FDA data

Heel/Elbow Protector

Primary DI
00810006683097
Brand
Heel/Elbow Protector
Company
PRIMO INC
Model
HEP01S
Catalog number
HEP01S
Device description
Heel/Elbow Protector - Small (knitted w/foam)
Published
2019-02-27
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
00810006683097PackageGS16In Commercial Distribution
00810006681857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810006683097008100066830978100066830970810006683097
00810006681857008100066818578100066818570810006681857

GMDN Terms#

Term, Definition table
TermDefinition
Arm/elbow protectorA device designed to be worn over the arm/elbow (various ranges from the base of the fingers to above the elbow) to provide a cover and/or cushion to protect the limb from friction and knocks against objects. It is typically made from soft padded materials and is held in place with bands or straps around the arm or can be elastic tubular in design so that it slides over the arm/elbow. It is typically used by persons that have tendencies for skin sores on their elbows/arms, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable 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