FDA.report

SuperPole™ FRS Pole with Receptacle

Primary DI
00689281005364
Brand
SuperPole™ FRS Pole with Receptacle
Company
Healthcraft Products Inc.
Model
FRS-PWR
Catalog number
00536
Device description
The SuperPole F.R.S. is a high quality, commercial grade support pole that interfaces with and is supported by a receptacle that is permanently embedded into a structural concrete floor. The SuperPole F.R.S. is intended for moderate vertical load bearing to provide sitting and standing support for people with reduced mobility. When the pole is removed, the receptacle must be covered with a floor flush cap to provide a water-tight seal. The maximum user weight for this product is 450lbs / 205kgs. 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
FMRDevice, Transfer, Patient, Manual

Product Code Classifications

CodeDeviceSpecialtyClass
FMRDevice, Transfer, Patient, ManualGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00689281005364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281005364006892810053646892810053640689281005364

GMDN Terms

TermDefinition
Freestanding support railA self-supporting bar that is placed strategically on the floor by a healthcare professional for hospitalized, disabled, or geriatric patients to hold and support themselves when rising from a bed or a chair.

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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