FDA.reportPublic FDA data

GENDRON

Primary DI
M368XHRVR21
Brand
GENDRON
Company
GF HEALTH PRODUCTS, INC.
Model
X-HR-VR-2
Device description
Supernal Bed Rail
Published
2025-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
M368XHRVR21PrimaryHIBCC0

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."

Contacts#

Phone, Email table
PhoneEmail
770-368-4700CS@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368FR601EPCHBN04271LUMEXFR601EPCHBN-04272026-09-18
M368FR601EPCHBN96071LUMEXFR601EPCHBN-96072026-09-18
M368FR601EPCHNN04271LUMEXFR601EPCHNN-04272026-09-18
M368FR601EPCNBN04271LUMEXFR601EPCNBN-04272026-09-18
M368FR601EPCNNN04271LUMEXFR601EPCNNN-04272026-09-18
M368FR601EPCOBN04271LUMEXFR601EPCOBN-04272026-09-18
M368FR601EPCONN04271LUMEXFR601EPCONN-04272026-09-18
M368FR601EPNHBN04271LUMEXFR601EPNHBN-04272026-09-18
M368FR601EPNHNN04271LUMEXFR601EPNHNN-04272026-09-18
M368FR601EPNHNN86021LUMEXFR601EPNHNN-86022026-09-18
M368FR601EPNNBN04271LUMEXFR601EPNNBN-04272026-09-18
M368FR601EPNNBN86041LUMEXFR601EPNNBN-86042026-09-18
M368FR601EPNNNN03171LUMEXFR601EPNNNN-03172026-09-18
M368FR601EPNNNN04271LUMEXFR601EPNNNN-04272026-09-18
M368FR601EPNOBN04271LUMEXFR601EPNOBN-04272026-09-18
M368FR601EPNONN04271LUMEXFR601EPNONN-04272026-09-18
M368FR601EPNONN13111LUMEXFR601EPNONN-13112026-09-18
M368FR601EUCHBN04271LUMEXFR601EUCHBN-04272026-09-18
M368FR601EUCHNN04271LUMEXFR601EUCHNN-04272026-09-18
M368IN601EPCHBNCOM1INTENSAIN601EPCHBN-COM2026-09-18

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