Home GUDID 04260764840564 MedibinoNEO ring – TG PUR Gel - Size M - PU6
Primary DI 04260764840564
Brand MedibinoNEO ring – TG PUR Gel - Size M - PU6
Company Kluba Medical GmbH
Model 1
Catalog number 24021703-M
Device description Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies, are less active and often lie in one position. As a result, certain body parts are exposed to increased pressure. As the bones of the skull are still very soft in the first months of life, the head is sensitive to permanent pressure. This is particularly critical for premature babies, as the skull is still softer due to the low maturity at birth. Premature babies often have to be monitored in the hospital for several months and also have to stay in an incubator. Head deformations, such as plagiocephaly, brachycephaly and dolichocephaly, are often the result of unilateral positioning of premature and newborn babies on their sides or backs. In studies, the incidence of head deformations in premature babies is reported to be up to 90 %. With the Medibino Neo positioning system, we provide a solution for pressure-relieving positioning and stabilisation of the mid-head position of premature babies and infants during long hospital stays.
Published 2024-09-06
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 FRP Holder, Infant Position PRN Pediatric Position Holder
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FMP Protector, Skin Pressure General Hospital 1 FRP Holder, Infant Position General Hospital 1 PRN Pediatric Position Holder General Hospital 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260764840564 Primary GS1 0 04260764840717 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260764840564 04260764840564 4260764840564 04260764840717 04260764840717 4260764840717
GMDN Terms# Term, Definition table Term Definition Infant recumbent sleep positioner A non-rigid device, usually made of flame retardant fabric and/or polyurethane foam materials, intended to modify the sleeping position/posture of infants to prevent deformational plagiocephaly, a flattening of the back of the skull from a consistent back-sleeping position. It is available in a variety of designs including a wedge-shaped head pillow, a sleeping garment (sleeveless vest) with hooks/Velcro fasteners/nylon zip fasteners and an insertable foam wedge, or a specially designed mattress. This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Regulatory Flags# DUNS number 313383362 Device count 6 Premarket exempt true Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04260764840557 MedibinoNEO ring – TG PUR Gel - Size L - PU 6 1 24021703-L 2024-09-06 04260764840571 MedibinoNEO ring – TG PUR Gel - Size S - PU6 1 24021703-S 2024-09-06 04260764840649 MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50 1 27021703-L 2024-09-06 04260764840656 MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50 1 27021703-M 2024-09-06 04260764840663 MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50 1 27021703-S 2024-09-06 04260764840670 MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50 1 31021703-L 2024-09-06 04260764840687 MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50 1 31021703-M 2024-09-06 04260764840694 MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50 1 31021703-S 2024-09-06 04260764840700 MedibinoNEO ring – TG PUR Gel - Size L - PU 6 1 24021703-L 2024-09-06 04260764840724 MedibinoNEO ring – TG PUR Gel - Size S - PU6 1 24021703-S 2024-09-06 04260764840793 MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50 1 27021703-L 2024-09-06 04260764840809 MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50 1 27021703-M 2024-09-06 04260764840816 MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50 1 27021703-S 2024-09-06 04260764840823 MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50 1 31021703-L 2024-09-06 04260764840830 MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50 1 31021703-M 2024-09-06 04260764840847 MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50 1 31021703-S 2024-09-06
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