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

Primary DI
04260764840700
Brand
MedibinoNEO ring – TG PUR Gel - Size L - PU 6
Company
Kluba Medical GmbH
Model
1
Catalog number
24021703-L
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
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260764840557PrimaryGS10
04260764840700Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260764840557042607648405574260764840557
04260764840700042607648407004260764840700

GMDN Terms#

Term, Definition table
TermDefinition
Infant recumbent sleep positionerA 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
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4921154212590info@kluba-medical.com

Regulatory Flags#

DUNS number
313383362
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6124021703-L2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6124021703-S2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50127021703-L2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50127021703-M2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50127021703-S2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50131021703-L2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50131021703-M2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50131021703-S2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6124021703-M2024-09-06
04260764840724MedibinoNEO ring – TG PUR Gel - Size S - PU6124021703-S2024-09-06
04260764840793MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50127021703-L2024-09-06
04260764840809MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50127021703-M2024-09-06
04260764840816MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50127021703-S2024-09-06
04260764840823MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50131021703-L2024-09-06
04260764840830MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50131021703-M2024-09-06
04260764840847MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50131021703-S2024-09-06

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