MedibinoNEO ring – TG PUR Gel - Size L - PU 6 24021703-L

GUDID 04260764840700

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.

Kluba Medical GmbH

Infant recumbent sleep positioner
Primary Device ID04260764840700
NIH Device Record Key0ef27e44-e951-4e72-aed9-5769de58f66e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedibinoNEO ring – TG PUR Gel - Size L - PU 6
Version Model Number1
Catalog Number24021703-L
Company DUNS313383362
Company NameKluba Medical GmbH
Device Count6
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com
Phone+4921154212590
Emailinfo@kluba-medical.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS104260764840557 [Primary]
GS104260764840700 [Unit of Use]

FDA Product Code

FMPProtector, Skin Pressure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-16
Device Publish Date2024-09-06

Devices Manufactured by Kluba Medical GmbH

04260764840700 - MedibinoNEO ring – TG PUR Gel - Size L - PU 62024-09-16Positioning 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.
04260764840700 - MedibinoNEO ring – TG PUR Gel - Size L - PU 62024-09-16 Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies
04260764840564 - MedibinoNEO ring – TG PUR Gel - Size M - PU62024-09-16 Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies
04260764840724 - MedibinoNEO ring – TG PUR Gel - Size S - PU62024-09-16 Positioning premature infants is a major challenge in intensive care. Newborn babies in general, but especially premature babies
04260764840793 - MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU502024-09-16 The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have NO inne
04260764840809 - MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU502024-09-16 The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have NO inne
04260764840816 - MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU502024-09-16 The MedibinoNeo ring has to be used with a fitting cover when it is clinically used for patient positioning. This disposable cov
04260764840823 - MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 502024-09-16 The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have a cenra
04260764840830 - MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU502024-09-16 The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have a cenra

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