FDA UDI In Commercial Distribution 🇺🇸 United States

Advantage Pole™ Portable Bariatric

DI: 00689281000550 · Model: AR-AP-P-HD · Healthcraft Products Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Advantage Pole™ Portable Bariatric
Primary DI
00689281000550
Version / Model
AR-AP-P-HD
Catalog Number
00055
Company Name
Healthcraft Products Inc.
Labeler DUNS
252468293
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-08-31
Public Version
1
Public Version Date
2021-09-08
Public Version Status
New
Public Device Record Key
4c3a1d3b-e883-4f70-b133-99b4309f20b4

Device Description

The Advantage Rail Portable is a high quality, commercial grade pivoting and locking horizontal bar that connects to a floor mounted mast. The horizontal bar can be lifted, pivoted and lowered to the next locking position around the mast. The Advantage Rai Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Rail Portable mast is installed to a structural floor. Inside the mast is a locking mechanism for the horizontal bar: a castellated collar with 8 grooves (every 45 degrees) to provide a mechanism strong enough to support the user. It is important to set proper height and orientation of the Advantage Rail Portable to optimize the user’s range of motion. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight. The Advantage Rail Portable is not to be used in any other way than described above. The Advantage Pole Portable is a high quality, commercial grade floor mounted support pole. The Advantage Pole Portable is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole Portable mast is installed to a structural floor. The maximum user weight is dependent on model. Note: Product is not intended to support full body weight.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
IKX Aid, Transfer

GMDN Terms

Code Name
41583 Freestanding support rail

Identifiers

Type ID
Primary 00689281000550