FDA.reportPublic FDA data

MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50

Primary DI
04260764840649
Brand
MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50
Company
Kluba Medical GmbH
Model
1
Catalog number
27021703-L
Device description
The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have NO inner filling and are fitting for the MedibinoNeo ring size L
Published
2024-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure
FRPHolder, Infant Position
PRNPediatric Position Holder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1
FRPHolder, Infant PositionGeneral Hospital1
PRNPediatric Position HolderGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260764840649PrimaryGS10
04260764840793Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260764840649042607648406494260764840649
04260764840793042607648407934260764840793

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

Contacts#

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

Regulatory Flags#

DUNS number
313383362
Device count
50
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 DIBrandModelCatalogPublished
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6124021703-L2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6124021703-S2024-09-06
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
04260764840700MedibinoNEO ring – TG PUR Gel - Size L - PU 6124021703-L2024-09-06
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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