MedibinoNEO Ring – TG PUR Gel – Size L – PU 6
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,…
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.
Who Else Makes It
Concentrated in Guangdong (31), Zhejiang (21), Jiangsu (19). 28 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Lingxian Dongsheng Textile Co., Ltd. | Dezhou | Shandong | Contract manufacturer | 23 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Anji Hengfeng Sanitary Material Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 20 |
| Jiangsu Reak Healthy Articles Co., Ltd. | Yangzhong | Jiangsu | Contract manufacturer | 18 |
| Shenzhen Zhouyang Medical Care Product Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Hubei Dacheng Medical Technology Co., Ltd. | Xianning | Hubei | Contract manufacturer | 12 |
| Dongguan Shihui Living Products Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Dongguan Vincent Rehab Devices Company Limited | Dongguan | Guangdong | Contract manufacturer | 11 |
| Premier Guard Zhongshan Limited | Zhongshan | Guangdong | Contract manufacturer | 10 |
| Dongguan Suscong Healthcare Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
Showing 12 of 101. All 101 manufacturers in China registered for Protector, Skin Pressure
Record
| Listed by | Kluba Medical GmbH |
|---|---|
| FDA product code | FMP |
| Device type | Protector, Skin Pressure |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6450 |
| Premarket notification | Exempt |
| Record published | 2024-09-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1 | Fits for premature infants weighting more than 2000g | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Action® | Action Products, Inc. | 485 |
| Primo | ASP Global, LLC | 147 |
| Allen | Hill-ROM, Inc. | 141 |
| Blue Diamond | David Scott Company. | 114 |
| DeRoyal | Deroyal Industries, Inc. | 85 |
| Primo/ASP Medical | ASP Global, LLC | 68 |
| Darco® Toe Cap | Darco (Europe) GmbH | 52 |
| Mölnlycke®Z-Flo™ Fluidized Positioner | Mölnlycke Health Care AB | 50 |
| TUFFease® | Innovative Medical Products, Inc. | 43 |
| Bioseal Inc. | Bioseal | 31 |
| Darco® PegContour™ Insole | Darco (Europe) GmbH | 26 |
| SpandaNette | Medi-Tech, Inc. | 23 |
Showing 12 of 783. All products under Protector, Skin Pressure
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.