FDA.reportPublic FDA data

Blue Diamond

Primary DI
15060797551064
Brand
Blue Diamond
Company
David Scott Company
Model
BD0100-24505
Catalog number
BD0100-24505
Device description
"This Blue Diamond® Gel Pad is a pressure management pad. All our gel pads are made in the USA and are designed to mimic human adipose tissue composition to help prolong the chance of pressure insults. Because of the size of this pad it is ideal for a peg board gel overlay. 24"" x 50"" x 1/2"""
Published
2022-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
15060797551064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1506079755106415060797551064

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, reusableA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.5Inch
Length50Inch
Width24Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
508-875-3333customerservice@davidscottco.com

Regulatory Flags#

DUNS number
073814568
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15060797551026NABD010BD0102022-07-07
15060797554232NADSC-800-0049BD1002025-01-10
15060797554645NABD-CC-PRBD-CC-PR2025-01-10
15060797554256NABD301BD3012025-01-03
15060797554140Blue DiamondDSC-800-0013DSC-SLPS2024-11-21
15060797554225NABD341BD3252024-11-21
15060797554133NABD330BD3302024-03-20
15060797554157NABD150BD1502024-03-20
15060797554034NABD311BD3252024-03-13
15060797554027NABD325BD3252024-01-17
15060797554119Blue DiamondBD170BD1702023-11-08
15060797554003David Scott CompanyDSC-610DSC-6102023-10-18
15060797554010David Scott CompanyDSC-611DSC-6112023-10-18
15060797554102David Scott CompanyBD2502023-10-16
15060797553839NABD100BD1002023-07-26
15060797553891NADSC-SLPSaDSC-SLPSa2023-07-26
15060797553945NADSC-800-0161DSC-800-01612023-07-26
15060797553136Blue DiamondDSC-SLPS-foam-12DSC-SLPS-foam-122022-07-18
15060797553150NADSC-TKS-PADDSC-TKS-PAD2022-07-18
15060797553167NADSC-TKS-RDSC-TKS-R2022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166028DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166035DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166073DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166141DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166158DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166165DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166172DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166189DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08