FDA UDI
In Commercial Distribution
🇺🇸 United States
Banana
DI: 05060405748100
·
Model: B-SOLOSLIDE200100
·
GBUK LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Banana
- Primary DI
- 05060405748100
- Version / Model
- B-SOLOSLIDE200100
- Catalog Number
- B-SOLOSLIDE200100
- Company Name
- GBUK LTD
- Labeler DUNS
- 738810980
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-01-24
- Public Version
- 1
- Public Version Date
- 2024-02-01
- Public Version Status
- New
- Public Device Record Key
- 55b0b77c-507c-4ede-9c7b-86130d96cf0f
Device Description
Banana, Flat, Slide Sheet, Single Use Reel of 50 Sheets 200 x 100cm
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IKX | AID, TRANSFER | Physical Medicine | 890.5050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37165 | Patient transfer/turning sheet, single-use | A manual device in the form of a sturdy sheet intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 85060405748106 | GS1 | ||||
| Primary | 05060405748100 | GS1 |