FDA.reportPublic FDA data

Banana

Primary DI
05060405747462
Brand
Banana
Company
GBUK GROUP LIMITED
Model
B-ASSIST
Catalog number
B-ASSIST
Device description
Banana Assist Single Patient Use Manual Handling Assistant 62cm x 230cm
Published
2023-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FMRDEVICE, TRANSFER, PATIENT, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060405747479PackageGS125Not in Commercial Distribution
05060405747486PackageGS12Not in Commercial Distribution
05060405749992PackageGS125In Commercial Distribution
05060405747462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060405747479050604057474795060405747479
05060405747486050604057474865060405747486
05060405749992050604057499925060405749992
05060405747462050604057474625060405747462

GMDN Terms#

Term, Definition table
TermDefinition
Patient transfer/turning sheet, single-useA manual device in the form of a non-inflatable sheet or mat 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.

Regulatory Flags#

DUNS number
220705343
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002550006EnteralVED-691VED-6912022-11-01
10850002550013EnteralVED-692VED-6922022-11-01
10850002550020EnteralVED-693VED-6932022-11-01
10850002550037EnteralVED-694VED-6942022-11-01
10850801006995EnteralVED-690VED-6902022-11-01
00850801006967EnteralVED-670VED-6702022-10-20
05056038302895TenderTipTT02-05-E31TT02-05-E312023-06-02
05056038302925TenderTipTT02-06-E31TT02-06-E312023-06-02
05056038302956TenderTipTT02-06-P31TT02-06-P312023-06-02
05056038302987TenderTipTT02-07-P31TT02-07-P312023-06-02
05056038303014TenderTipTT02-08-E31TT02-08-E312023-06-02
05056038303045TenderTipTT02-08-P31TT02-08-P312023-06-02
05056038303083TenderTipTT02-10-E54-NTT02-10-E54-N2023-06-02
05056038303137TenderTipTT02-12-E54-NTT02-12-E54-N2023-06-02
05056038303175TenderTipTT02-12-T34-NTT02-12-T34-N2023-06-02
05056038303212TenderTipTT02-14-E54-NTT02-14-E54-N2023-06-02
05056038303250TenderTipTT02-14-T34-NTT02-14-T34-N2023-06-02
05056038303298TenderTipTT03-12-E54-NTT03-12-E54-N2023-06-02
05056038303335TenderTipTT03-12-T34-NTT03-12-T34-N2023-06-02
05056038303373TenderTipTT03-14-E54-NTT03-14-E54-N2023-06-02

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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15059441537295AIRPALArjohuntleigh ABFMR2026-03-23
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15059441537318AIRPALArjohuntleigh ABFMR2026-03-23
15059441537325AIRPALArjohuntleigh ABFMR2026-03-23
15059441537332AIRPALArjohuntleigh ABFMR2026-03-23
15059441537349AIRPALArjohuntleigh ABFMR2026-03-23
00816299011500HoverCover SlideHovertech InternationalFMR2026-01-12
00810113682730ManaSlideManamed, Inc.FMR2025-11-25
07613327632842Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCFMR2025-11-19
0078755104129340649 Air-Assist +XODUS MEDICAL, INC.FMR2025-10-24
0078755104130940650 Air-Assist EXTXODUS MEDICAL, INC.FMR2025-10-24
00816299012569HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012576HoverMatt PROS Hovertech InternationalFMR2025-09-10
00816299012781HoverMatt PROS Hovertech InternationalFMR2025-09-10
10197344161249MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-07-11
20197344154958MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-04-23
10193489021141MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-02-14
0078755104000540685 Air Assist Power Lift - 120VACXODUS MEDICAL, INC.FMR2025-02-04
0078755104074640999 Air Assist Power Lift - 220VACXODUS MEDICAL, INC.FMR2025-02-04
10193489000658MEDLINEMEDLINE INDUSTRIES, INC.FMR2025-01-03
10603354130200BAMEHOB INCFMR2024-09-12
10603354130248BAMEHOB INCFMR2024-09-12
10603354130262BAMEHOB INCFMR2024-09-12
10603354130286BAMEHOB INCFMR2024-09-12
10603354130309BAMEHOB INCFMR2024-09-12
10603354130323BAMEHOB INCFMR2024-09-03
10603354130347BAMEHOB INCFMR2024-09-03
10603354130361BAMEHOB INCFMR2024-09-03