FDA.reportPublic FDA data

BIOS Living

Primary DI
10057475268388
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
Rx
false
OTC
true
Sterile
false
Single use
false

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
BedrailA 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.

Sterilization Methods#

Method table
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#

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