| Primary Device ID | 04260764840564 |
| NIH Device Record Key | c037429f-bbb3-41b0-a090-286b46ff6c4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MedibinoNEO ring – TG PUR Gel - Size M - PU6 |
| Version Model Number | 1 |
| Catalog Number | 24021703-M |
| Company DUNS | 313383362 |
| Company Name | Kluba Medical GmbH |
| Device Count | 6 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 04260764840700 - MedibinoNEO ring – TG PUR Gel - Size L - PU 6 | 2024-09-16 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 - PU6 | 2024-09-16Positioning 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. |
| 04260764840564 - MedibinoNEO ring – TG PUR Gel - Size M - PU6 | 2024-09-16 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 - PU6 | 2024-09-16 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 - PU50 | 2024-09-16 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 - PU50 | 2024-09-16 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 - PU50 | 2024-09-16 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 50 | 2024-09-16 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 - PU50 | 2024-09-16 The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have a cenra |