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
Update
Distribution status
Not 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
10057475268388PackageGS15Not in 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.

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
00057475244125BIOS DiagnosticsBD4122026-08-07
00057475000561BIOS Living59056L2023-03-31
00057475000578BIOS Living59057L2023-03-31
00057475000585BIOS Living59058L2023-03-31
00057475032500BIOS DiagnosticsW2502026-01-19
00057475160517BIOS DiagnosticsNS1602024-06-17
00057475210175BIOS LivingLK0172023-09-15
00057475210182BIOS LivingLK0182023-09-15
00057475210229BIOS LivingLK0222023-09-18
00057475210427BIOS LivingLK0422023-03-31
00057475210434BIOS LivingLK0432023-03-31
00057475210441BIOS LivingLK0442023-03-31
00057475210458BIOS LivingLK0452023-03-31
00057475210465BIOS LivingLK0462023-03-31
00057475210472BIOS LivingLK0472023-03-31
00057475210489BIOS LivingLK0482023-03-31
00057475211301BIOS LivingLK1302023-09-18
00057475220495BIOS Diagnostics220DI2023-09-20
00057475239497BIOS239DI2023-05-23
00057475242015BIOSBD2012022-03-04

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