AccessGUDID - DEVICE: EasyShift (00860004936817)

GUDID

Device Identifier (DI) Information

Brand Name: EasyShift
Version or Model: EAS-42-Z
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Seneca Devices, Inc.

Primary DI Number: 00860004936817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117658378 *Terms of Use

Device Description: EasyShift Repositioning System V3 for 42" wide mattress, compatible with EasyShift Zipper Sheet

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?
43268	Bed mattress support platform, hydraulic	A hydraulically-powered medical bed structure that supports a medical bed patient surface (e.g., a mattress) and that can articulate and/or change its surface to facilitate various therapeutic, diagnostic, and convenience positions. It is typically a flat structure made of a metal frame that operates in response to hand and foot controls.	Active	false
66260	Intensive-care patient transport system, ventilatory support, neonatal	A mobile (on wheels) assembly of devices intended to be used to transport a neonatal patient (e.g., between healthcare facilities) with the in-transit provision of high-level critical care, especially ventilatory support (but not extracorporeal life support). It includes a neonatal incubator, ventilatory equipment (e.g., ventilator, nitric oxide delivery unit), infusion equipment [e.g., syringe driver(s), infusion pump], and patient monitors, mounted upon a patient trolley/stretcher; emergency airway clearing/resuscitation equipment may also be included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNK	Bed, Hydraulic, Adjustable Hospital
IKZ	Bed, Patient Rotation, Powered

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: b18f338a-997e-4b97-9335-674754af5dee
Public Version Date: January 22, 2024
Public Version Number: 1
DI Record Publish Date: January 12, 2024