AccessGUDID - DEVICE: EasyBoost 400 (00860004936824)

GUDID

Device Identifier (DI) Information

Brand Name: EasyBoost 400
Version or Model: ESB-400H
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Seneca Devices, Inc.

Primary DI Number: 00860004936824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117658378 *Terms of Use

Device Description: Air blower unit (with hook) for use with EasyBoost Cushion, for safe working load up to 400 lbs

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?
30032	Electrical assistive bed	A mains electricity (AC-powered) bed designed for a person with a disability and operated by the occupant and/or an attendant using controls that activate electrically-powered motors that adjust the positioning of the mattress. It may have one or more sections of the mattress support platform that can be adjusted in height and/or angle.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNG	Lift, Patient, Ac-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: a12c382b-894c-41e2-a3de-ff683f7eefce
Public Version Date: October 25, 2024
Public Version Number: 1
DI Record Publish Date: October 17, 2024