FDA.reportPublic FDA data

BIOS Living

Primary DI
10057475247154
Brand
BIOS Living
Company
Thermor Ltd
Model
BD715
Device description
Bathtub Safety Rail
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10057475247154PackageGS14In Commercial Distribution
00057475247157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747524715410057475247154
00057475247157000574752471570574752471570057475247157

GMDN Terms

TermDefinition
Bath hand railA bar intended to provide a supportive hand-hold for a person with a disability when raising or lowering themselves or changing their body position while bathing in a bath or bathing facility. It will typically be affixed to or around the bath.

Sterilization Methods

Method

Regulatory Flags

DUNS number
246883458
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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

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20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
20057475260945BIOS LivingLF0942024-08-19
20057475260952BIOS LivingLF0952024-08-19
20057475260976BIOS LivingLF0972024-08-19
20057475260990BIOS LivingLF0992024-08-19
10057475267756BIOS LivingLF7752024-08-19
10057475267763BIOS LivingLF7762024-08-19
10057475281943BIOS LivingLH1942024-08-19
10057475283008BIOS LivingLH3002024-08-19
10057475960015BIOS LivingSP0012024-08-19
20057475611037BIOS LivingFA1032024-07-02
20057475611044BIOS LivingFA1042024-07-02
20057475611051BIOS LivingFA1052024-07-02
20057475611068BIOS LivingFA1062024-07-02
20057475611075BIOS LivingFA1072024-07-02
20057475611204BIOS LivingFA1202024-07-02
10057475160514BIOS DiagnosticsNS1602024-06-17

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00745129278366Sigvaris DOFF N’ DONNER SET – Single UnitSIGVARIS INCIKX2026-03-11
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00850015884986easycareSynchronis Medical, LLCIKX2026-02-20
00850063404006easycareSynchronis Medical, LLCIKX2026-02-20
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00850063404044easycareSynchronis Medical, LLCIKX2026-02-20
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00850063404167easycareSynchronis Medical, LLCIKX2026-02-13
00850063404181easycareSynchronis Medical, LLCIKX2026-02-13
10810132043007HCSConcordance Healthcare Solutions LLCIKX2026-01-23
10810132043014HCSConcordance Healthcare Solutions LLCIKX2026-01-23
00745129273859579 Melany Donning & Doffing SmallSIGVARIS INCIKX2026-01-19
00745129273866579 Melany Donning & Doffing Extra SmallSIGVARIS INCIKX2026-01-19
00745129273835579 Melany Donning & Doffing LargeSIGVARIS INCIKX2026-01-09
00745129273842579 Melany Donning & Doffing MEDIUMSIGVARIS INCIKX2026-01-09
00810178884940ViveVIVE HEALTH LLCIKX2026-01-08
00810178885015ViveVIVE HEALTH LLCIKX2026-01-08
10810178884206ViveVIVE HEALTH LLCIKX2025-12-06
00810178884582ViveVIVE HEALTH LLCIKX2025-12-05
00841027102441Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102458Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102465Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26
00841027102632Pedigo Products, Inc. PEDIGO PRODUCTS, INC.IKX2025-11-26