FDA.report

Blue Diamond

Primary DI
15060797552078
Brand
Blue Diamond
Company
David Scott Company
Model
BD2560
Catalog number
BD2560
Device description
Blue Diamond® Flat Bottom Chest Roll. These viscoelastic polymer gel pads have a thin thermoformed skin and simulate human adipose tissue. They are a versatile roll used for axillary, shoulders, chest distensions, under knees, as well as bolster rolls to keep patients in place. A wide variety of shaped & sizes are available. This particular one is a smaller pediatric size
Published
2022-07-07
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

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15060797552078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1506079755207815060797552078

GMDN Terms

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

TypeValueUnit
Height3Inch
Length3Inch
Width12Inch

Sterilization Methods

Method

Contacts

PhoneEmail
508-875-3333customerservice@davidscottco.com

Regulatory Flags

DUNS number
073814568
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
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
15060797554232NADSC-800-0049BD1002025-01-10
15060797554263Blue DiamondBD2190BD21902025-01-10
15060797554645NABD-CC-PRBD-CC-PR2025-01-10
15060797554256NABD301BD3012025-01-03
15060797554140Blue DiamondDSC-800-0013DSC-SLPS2024-11-21
15060797554225NABD341BD3252024-11-21
15060797554218NADSC-36363DSC-363632024-11-19
15060797553341NAWSHP0101WSHP01012024-04-23
15060797553358NAWSHP0102WSHP01022024-04-23
15060797553365NAWSHP0102-MWSHP0102-M 2024-04-23
15060797553372NAWSHP0103WSHP0103 2024-04-23
15060797553389NAWSHP0103-MWSHP0103-M2024-04-23
15060797553396NAWSHP-PEWSHP-PE2024-04-23
15060797554294NAWSHP0104-PRWSHP0104-PR2024-04-23
15060797554058NADSC-800-0396DSC-800-03962024-04-17
15060797554188David Scott Company DSC-1009-001DSC-1009-0012024-03-21
15060797553648Blue DiamondBDAB26BDAB262024-03-20
15060797554065NADSC-800-0271DSC-800-02712024-03-20
15060797554133NABD330BD3302024-03-20
15060797554157NABD150BD1502024-03-20

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