FDA UDI
In Commercial Distribution
🇺🇸 United States
MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50
DI: 04260764840663
·
Model: 1
·
Kluba Medical GmbH
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- MedibinoNEO disposable Cover cotton knit WITHOUT soft granules - Size S - PU50
- Primary DI
- 04260764840663
- Version / Model
- 1
- Catalog Number
- 27021703-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
- 396f2e2e-7fac-415f-b9ef-c2abe661488c
Device Description
The MedibinoNeo ring has to be used with a fitting cover when it is clinically used for patient positioning. This disposable cover is fitting for the Medibino ring size S and has NO inner filling.
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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
| FRP | Holder, Infant Position | General Hospital | 880.5680 | 1 |
| PRN | Pediatric Position Holder | General Hospital | 880.5680 | 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 | 04260764840816 | GS1 | ||||
| Primary | 04260764840663 | GS1 |
Customer Contacts
- Phone
- +4921154212590
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Accessory that fits for the MedibinoNeo gel ring Size S |