AccessGUDID - DEVICE: XpeditionTM Powered Stair Chair (mid configuration) (07613327581607)

GUDID

Device Identifier (DI) Information

Brand Name: XpeditionTM Powered Stair Chair (mid configuration)
Version or Model: 625705550002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 625705550002
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327581607
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078470558 *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):	Yes
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?
16906	Stair chair	A device in which a disabled or infirm person sits in order to be manually transported by attendants/nursing staff up or down a flight of stairs. The device is typically constructed with hand bars, locking/opening bars or straps, and reinforced legs, with or without wheels, to facilitate patient transport on stairs. The device is typically used in emergency situations.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILK	Transport, patient, powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222818	000

Device Exempt from Premarket Submission: No 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
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 149 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Temperature: between -40 and 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cc9e4443-36a9-4108-b9c8-aa6cb8599b20
Public Version Date: May 04, 2023
Public Version Number: 1
DI Record Publish Date: April 26, 2023