Home GUDID 00810055880324 Foam Products
Primary DI 00810055880324
Brand Foam Products
Company JOERNS HEALTHCARE, LLC
Model 8807EA
Device description "7"" Donut positioner "
Published 2023-08-11
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name FMP Protector, Skin Pressure
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMP Protector, Skin Pressure General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20810055880328 Package GS1 24 In Commercial Distribution 00810055880324 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20810055880328 20810055880328 00810055880324 00810055880324 810055880324 0810055880324
GMDN Terms# Term, Definition table Term Definition Freestanding patient positioner, reusable A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a reusable device.
Regulatory Flags# DUNS number 790937150 Device count 1 DM exempt true Premarket exempt true Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00810055880126 Slings NA25705 NA25705 2025-07-22 00810055884865 Dolphin Fluid Immersion Simulation DLPH-3382OOEUJ-M DLPH-3382OOEUJ-M 2025-07-10 00857268006707 Dolphin Fluid Immersion Simulation DLPH-4282LPOOJ-M DLPH-4282LPOOJ-M 2025-07-10 00857268006851 Dolphin Fluid Immersion Simulation DLPH-4882LPOOJ-M DLPH-4882LPOOJ-M 2025-07-10 00857268006875 Dolphin Fluid Immersion Simulation DLPH-3582OO4WJ-M DLPH-3582OO4WJ-M 2025-07-10 00857268006752 Dolphin Fluid Immersion Simulation DLPH-1717WCOOJ-C DLPH-1717WCOOJ-C 2025-07-08 00857268006295 Dolphin Fluid Immersion Simulation DLPH-3582OOOOJ-M DLPH-3582OOOOJ-M 2025-07-07 00857268006257 Dolphin Fluid Immersion Simulation FIS Step-deck DLPH-3588OVOOJ-M 2016-09-06 00857268006417 Dolphin Fluid Immersion Simulation DLPH-3582OOOOJ-M 2016-09-02 00810055884834 Panacea - DS PAN1000-FLEX-RILG2 PAN1000-FLEX-RILG2 2025-06-18 00810055884841 Panacea - DS PAN1K-FLEX-RILG2QS PAN1K-FLEX-RILG2QS 2025-06-18 00810055884858 Panacea - DS PAN1000-FLEX-RAHG2 PAN1000-FLEX-RAHG2 2025-06-18 00857268006868 Dolphin FIS DLPP-2850CBJ-M DLPP-2850CBJ-M 2025-05-29 00857268006271 Dolphin Fluid Immersion Simulation DLPH-3582OOOOJ-M 2017-08-22 00857268006424 Dolphin Fluid Immersion Simulation DLPH-3582LPOOOJ-M DLPH-3582LPOOOJ-M 2016-09-02 00857268006714 Dolphin Fluid Immersion Simulation DLPH-4882OOOOJ-M 2017-08-22 00857268006318 Dolphin Fluid Immersion Simulation DLPH-4282OOOOJ-M 2017-08-22 00857268006394 Dolphin Fluid Immersion Simulation FIS Stretcher DLPH-3176OSOOJ-P 2016-09-02 00857268006400 Dolphin Fluid Immersion Simulation DLPH-1717WCOOJ-C 2016-09-02 00857268006455 Dolphin Fluid Immersion Simulation DLPH-4282LPOOJ-M DLPH-4282LPOOJ-M 2016-09-02
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