FDA.reportPublic FDA data

BIOS Living

Primary DI
00057475268381
Brand
BIOS Living
Company
Thermor Ltd
Model
LF838
Device description
Bed Rail
Published
2023-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
QTCAdult Portable Bed Rails For Medical Purposes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTCAdult Portable Bed Rails For Medical PurposesPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10057475268388PackageGS15In Commercial Distribution
00057475268381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005747526838810057475268388
00057475268381000574752683810574752683810057475268381

GMDN Terms#

Term, Definition table
TermDefinition
Bedrail"A rigid, adjustable device that is mounted to the side or sides of a medical bed and, when in an ""up"" position, identifies the edge of the mattress support platform, providing a physical barrier intended to reduce the risk of accidental patient falls out of the bed. It may also enable the patient to independently sit up and/or change position while in bed. It may be a detachable component of the bed or integral to the overall construction of the bed. It is typically made of metal and/or plastic materials and is constructed to either lower or fold when the occupant vacates the bed or when not in use. It is not intended to be a patient restraint."

Regulatory Flags#

DUNS number
246883458
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00057475032500BIOS DiagnosticsW2502026-01-19
00057475491505BIOS DiagnosticsNS1502026-01-19
20057475032504BIOS DiagnosticsW2502026-01-19
00057475242909BIOS DiagnosticsBD2902026-01-19
10057475491502BIOS DiagnosticsNS1502026-01-19
00057475820213BIOS LivingRL0212026-01-19
00057475220495BIOS Diagnostics220DI2023-09-20
00057475282493BIOS282DI2023-05-23
00057475282738BIOS LivingLH2732024-03-21
00057475282745BIOS LivingLH2742024-03-21
00057475561017BIOS LivingEP1012024-03-22
00057475561024BIOS LivingEP1022024-03-22
00057475561031BIOS LivingEP1032024-03-23
00057475561048BIOS LivingEP1042024-03-23
00057475561055BIOS LivingEP1052024-03-22
00057475561062BIOS LivingEP1062024-03-22
00057475561079BIOS LivingEP1072024-03-22
00057475561086BIOS LivingEP1082024-03-22
00057475561093BIOS LivingEP1092024-03-22
00057475561222BIOS LivingEP1222024-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979878770299CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-05-16
06979878770305CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-05-16
06979878770244DALTONFujian Pacific Medical Manufacturing Co.,LtdQTC2026-04-17
06979878770251DALTONFujian Pacific Medical Manufacturing Co.,LtdQTC2026-04-17
00884389102865MEDLINEMEDLINE INDUSTRIES, INC.QTC2026-04-02
06979878770145CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
06979878770152CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
06979878770169CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
06979878770176CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
06979878770183CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
06979878770190CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
06979878770206CostcareFujian Pacific Medical Manufacturing Co.,LtdQTC2026-03-17
00369771005684GeriGentleEQJIANGMEN ELITE MEDICAL EQUIPMENT LTDQTC2026-02-09
00369771005691GeriGentleEQJIANGMEN ELITE MEDICAL EQUIPMENT LTDQTC2026-02-09
00369771005707GeriGentleEQJIANGMEN ELITE MEDICAL EQUIPMENT LTDQTC2026-02-09
06979196001136Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-19
06979196001143Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-19
06979196000429Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000436Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000443Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000450Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000467Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000474Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000481Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000498Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000504Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000511Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000665Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000672Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18
06979196000689Bed Rails for Elderly AdultsZhongshan Yungu daily products Co., LTD.QTC2025-12-18