FDA.report

Smart Rail 1 Pack

Primary DI
10689281019849
Brand
Smart Rail 1 Pack
Company
Healthcraft Products Inc.
Model
SRS-S-1PK
Catalog number
01984
Device description
The Smart-Rail is a bed rail with 2 positions: closed and opened. In the closed position, the rail is latched to the support frame to assist with in-bed positioning. In the opened position, the rail is unlatched from the support frame and pivoted out to the optimal location to assist with sitting and standing. The Smart-Rail is intended ONLY for moderate vertical load bearing to provide bed positioning, sitting and standing support for people with reduced mobility. The Smart-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. In the closed position, the Smart-Rail is height adjustable to accommodate the thickness of the mattress. In the opened position, the Smart-Rail is height adjustable to accommodate the height of the user. The maximum user weight for this product is 300lbs / 136kgs. Product is not intended to support full body weight.
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IKXAid, Transfer

Product Code Classifications

CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10689281019849PackageGS14In Commercial Distribution
00689281019842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1068928101984910689281019849
00689281019842006892810198426892810198420689281019842

GMDN Terms

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

Regulatory Flags

DUNS number
252468293
Device count
1
DM exempt
true
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

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