FDA.report

Advantage Pole Bariatric

Primary DI
00689281000482
Brand
Advantage Pole Bariatric
Company
Healthcraft Products Inc.
Model
AR-AP-HD
Catalog number
0048
Device description
The Advantage Pole is a high quality, commercial grade floor mounted support pole. The Advantage Pole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole mast is installed to a structural floor. The maximum user weight is 450lbs / 205kgs. Note: 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
00689281000482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00689281000482006892810004826892810004820689281000482

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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