FDA.report

Blue Diamond

Primary DI
05060797551968
Brand
Blue Diamond
Company
David Scott Company
Model
BD2480
Catalog number
BD2480
Device description
Blue Diamond® right Chest Positioner is a unique gel shape primarily used unde the ribcage to elevate the right side of the patient.
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
15060797551972PrimaryGS10
05060797551968Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1506079755197215060797551972
05060797551968050607975519685060797551968

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
Depth2Inch
Length28Inch
Width8Inch

Sterilization Methods

Method

Contacts

PhoneEmail
508-875-3333customerservice@davidscottco.com

Regulatory Flags

DUNS number
073814568
Device count
2
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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50749756401444DeRoyalDEROYAL INDUSTRIES, INC.FMP2026-01-01