AccessGUDID - DEVICE: Patient Loading Utility System (PLUS) (00810050862646)

GUDID

Device Identifier (DI) Information

Brand Name: Patient Loading Utility System (PLUS)
Version or Model: P7201-01-017
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFEPORT, LLC

Primary DI Number: 00810050862646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556196210 *Terms of Use

Device Description: PLUS, 66 IN STRUCTURE

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?
60489	Ambulance stretcher docking device	A device designed to be installed within an ambulance to facilitate the manual docking and locking of an ambulance stretcher to an ambulance, and secure the stretcher during transportation. It consists of a docking point(s) that may include a manual lifting/guiding mechanism.	Active	false
43438	Non-fixed medical gas cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	Stand, Infusion
CAN	Regulator, Pressure, Gas Cylinder

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: 73eb7259-a9d8-48f6-a48a-cd426c08ea22
Public Version Date: November 01, 2023
Public Version Number: 1
DI Record Publish Date: October 24, 2023