AccessGUDID - DEVICE: iN∫X ® (00190790001308)

GUDID

Device Identifier (DI) Information

Brand Name: iN∫X ®
Version or Model: 0015808
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: FERNO-WASHINGTON, INC.

Primary DI Number: 00190790001308
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 004239034 *Terms of Use

Device Description: iN∫X ® for 175, Integrated Patient Transport & Loading System – DWL

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?
60487	Ambulance stretcher, electrohydraulic	A battery-powered device consisting of a platform mounted on a wheeled frame, intended for use by emergency medical services (EMS) primarily to facilitate easy transport of a recumbent patient to and from ambulance vehicles (e.g., automobiles, aircraft, boats), whilst allowing the operator to raise and lower the platform using powered switches. It has an electrically-powered hydraulic undercarriage (e.g., X-frame) which can raise/lower the patient and is collapsible for ambulance loading; ambulance-mounted locking/docking devices may be included. The patient platform is typically hydraulically adjustable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPO	Stretcher, Wheeled

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: 1f484cd9-8a00-499d-b3de-3dd1e178d0c2
Public Version Date: February 22, 2019
Public Version Number: 3
DI Record Publish Date: February 13, 2017