FDA.reportPublic FDA data

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

Product Codes#

Code, Name table
CodeName
IKXAid, Transfer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKXAid, TransferPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10689281019849PackageGS14In Commercial Distribution
00689281019842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068928101984910689281019849
00689281019842006892810198426892810198420689281019842

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"GB-12-BS037342026-04-14
00689281010382e2™ Ceiling Mount Trapeze with 24 in. Grab BarSTP-CM-24010382021-08-25
00689281010450e2™ Ceiling Mount Trapeze with 32 in. Grab BarSTP-CM-32010452021-08-25
00689281037204PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29
00689281037228PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
00689281037235PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
00689281037242PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
00689281037259PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
00689281037266PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
00689281037303"Easy Mount™ Grab Bar, 1.25x12"", Oil Rubbed Bronze"GB-12-ORB 037302024-01-29
00689281037310"Easy Mount™ Grab Bar, 1.25x18"", Oil Rubbed Bronze"GB-18-ORB037312024-01-29
00689281037327"Easy Mount™ Grab Bar, 1.25x24"", Oil Rubbed Bronze"GB-24-ORB037322024-01-29
10689281037201PLUS Crescent Grab Bar, Oil Rubbed BronzePLUS-CGB-ORB037202024-01-29
00689281037211PLUS Shampoo Shelf + Grab Bar, Oil Rubbed BronzePLUS-SHS-ORB037212024-01-29
10689281037225PLUS Corner Shelf + Grab Bar, Oil Rubbed BronzePLUS-CS-ORB 037222024-01-29
10689281037232PLUS Towel Bar + Grab Bar, Oil Rubbed BronzePLUS-TB24-ORB 037232024-01-29
10689281037249PLUS Towel Hook, Oil Rubbed BronzePLUS-TH-ORB037242024-01-29
10689281037256PLUS Towel Ring + Grab Bar, Oil Rubbed BronzePLUS-TR-ORB037252024-01-29
10689281037263PLUS Toilet Paper Holder, Oil Rubbed BronzePLUS-TP-ORB 037262024-01-29
10689281037300Easy Mount™ Grab Bar, 1.25x12", Oil Rubbed BronzeGB-12-ORB 037302024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00689281037334"Easy Mount™ Grab Bar, 1.25x12"", Brushed Stainless"Healthcraft Products Inc.IKX2026-04-14
10194484320772CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320789CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320796CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320802CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320819CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320826CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320833CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320840CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320857CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320864CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320871CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320895CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320901CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320918CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320925CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320932CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320949CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320956CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320963CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320970CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320987CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484320994CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321007CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321014CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321021CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321038CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321045CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321052CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30
10194484321069CONDORGRAINGER INTERNATIONAL, INC.IKX2025-06-30