FDA.reportPublic FDA data

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

Primary DI
04260764840809
Brand
MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50
Company
Kluba Medical GmbH
Model
1
Catalog number
27021703-M
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 M.
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRPHolder, Infant Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRPHolder, Infant PositionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260764840656PrimaryGS10
04260764840809Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260764840656042607648406564260764840656
04260764840809042607648408094260764840809

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
50
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260764840557MedibinoNEO ring – TG PUR Gel - Size L - PU 6Kluba Medical GmbHFRP2024-09-06
04260764840571MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHFRP2024-09-06
04260764840649MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size L - PU50Kluba Medical GmbHFRP2024-09-06
04260764840656MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size M - PU50Kluba Medical GmbHFRP2024-09-06
04260764840663MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50Kluba Medical GmbHFRP2024-09-06
04260764840670MedibinoNEO disposable cover cotton knit WITH soft granules - Size L - PU 50Kluba Medical GmbHFRP2024-09-06
04260764840687MedibinoNEO disposable cover cotton knit WITH soft granules - Size M - PU50Kluba Medical GmbHFRP2024-09-06
04260764840694MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHFRP2024-09-06
04260764840564MedibinoNEO ring – TG PUR Gel - Size M - PU6Kluba Medical GmbHFRP2024-09-06
04260764840724MedibinoNEO ring – TG PUR Gel - Size S - PU6Kluba Medical GmbHFRP2024-09-06
04260764840847MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50Kluba Medical GmbHFRP2024-09-06
00610570004812DANNY SLING 10-18 LBSBird & Cronin, LLCFRP2022-08-20
00610570004850DANNY SLING 2-5 LBSBird & Cronin, LLCFRP2022-08-20
00610570006755DANNY SLING 5-9 LBSBird & Cronin, LLCFRP2022-08-20
00610570007301KERRY KUDDLER 18-40 LBSBird & Cronin, LLCFRP2022-08-20