MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50

Basic Information

• Brand Name: MedibinoNEO disposable cover cotton knit WITH soft granules - Size S - PU50
• Primary DI: 04260764840694
• Version / Model: 1
• Catalog Number: 31021703-S
• Company Name: Kluba Medical GmbH
• Labeler DUNS: 313383362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-09-06
• Public Version: 1
• Public Version Date: 2024-09-16
• Public Version Status: New
• Public Device Record Key: ecd8ca68-6122-486c-b458-85daa3d9dbc8

Device Description

The MedibinoNeo positioning ring has to be used with a fitting cover during clinical usage. These disposable covers have a cenral inner filling with soft granules and are fitting for the MedibinoNeo ring size S

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRP	Holder, Infant Position	General Hospital	880.5680	1
PRN	Pediatric Position Holder	General Hospital	880.5680	1
FMP	Protector, Skin Pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44294	Infant recumbent sleep positioner	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04260764840847	GS1
Primary	04260764840694	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Accessory, fits for the MedibinoNeo gel ring Size S