FDA.report

CRADLES HEEL & ELBOW PROTECTOR

Primary DI
00610570002467
Brand
CRADLES HEEL & ELBOW PROTECTOR
Company
Bird & Cronin, LLC
Model
08140424
Published
2022-08-20
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

Related Records

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00610570002467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00610570002467006105700024676105700024670610570002467

GMDN Terms

TermDefinition
Elbow/ankle friction/impact protectorA device designed to be worn over the elbow and/or the ankle to provide a cushion to protect the joint(s) from friction against surfaces and knocks against objects. It is typically made from soft padded materials and held in place with straps; it is designed to cover only the joint(s) and is not intended to cover a larger portion of the arm or leg. It is typically used by persons that have tendencies for skin sores on their elbows, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
045975349
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 DIBrandModelCatalogPublished
00610570191390B-Cool Chest & AB Binder Wrap081425212023-05-23
00610570191406B-Cool Chest & AB Binder Wrap081425222023-05-23
00610570191413B-Cool Chest & AB Binder Wrap081425242023-05-23
50610570191418B-Cool Chest & AB Binder Wrap081425232023-05-23
00610570191451B-Cool Super Sling Plus Universal (Complete Set)081482612023-02-20
00610570191581Short Anklizer Low Profile Walker XS081491372023-02-20
00610570191598Short Anklizer Low Profile Walker Small081491382023-02-20
00610570191604Short Anklizer Low Profile Walker Medium081491392023-02-20
00610570191611Short Anklizer Low Profile Walker Large081491402023-02-20
00610570191628Short Anklizer Low Profile Walker X-LG081491412023-02-20
00610570191444B-Cool Super Sling Universal (Sling Only)081482602023-02-16
00610570063277APNEA HEAD & CHIN STRAP081482232022-10-31
00610570088065CONTOURED CERV COLLAR 2" UNIV081400392022-10-31
00610570115655PRODY BULB HOLDER081482202022-10-31
00610570166756UNIVERSAL ARM SLING081400152022-08-01
00610570174607ENVELOPE STYLE ARM SLING XS081400612022-08-02
00610570174614ENVELOPE STYLE ARM SLING SM081400622022-08-02
00610570174621ENVELOPE STYLE ARM SLING MD081400632022-08-02
00610570174638ENVELOPE STYLE ARM SLING LG081400642022-08-02
00610570174645ENVELOPE STYLE ARM SLING XL081400652022-08-02

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