AccessGUDID - DEVICE: STAIRS,ADA STRAIGHT,11" DEEP STEP (00840314803986)

GUDID

Device Identifier (DI) Information

Brand Name: STAIRS,ADA STRAIGHT,11" DEEP STEP
Version or Model: 1582
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hausmann Enterprises, LLC

Primary DI Number: 00840314803986
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001892660 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35058	Stair-climbing exerciser, non-powered	An exercise apparatus designed to simulate the motion of climbing stairs primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period (aerobics); it also promotes lower-body muscle strength. It may consist of static staircases, or steppers (also known as climbers) consisting of foot pedals or platforms with a manual/hydraulic/air piston drive system, and with side handrails and/or front handlebars. It may include workout program modes to adjust the resistance level, a monitor to display the workout time, distance, speed, calories burned, and heart rate; and handlebars with grip pulse sensors or wireless heart rate tools.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ION	Exerciser, Non-Measuring

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 795ea79c-2ff3-4ee1-9ef7-a13131b6e126
Public Version Date: August 24, 2022
Public Version Number: 1
DI Record Publish Date: August 16, 2022