AccessGUDID - DEVICE: LF (10746190003885)

GUDID

Device Identifier (DI) Information

Brand Name: LF
Version or Model: DL814001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Liebel-Flarsheim Company LLC

Primary DI Number: 10746190003885
Issuing Agency: GS1
Commercial Distribution End Date: March 07, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 080186051 *Terms of Use

Device Description: OptiStar Elite MR Contrast Delivery System, Demo Loan

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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):	Yes
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?
58002	MRI contrast medium injection system, line-powered, stationary	An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for magnetic resonance imaging (MRI) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using MRI). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for MRI studies, and is stationary. It may interface with the MRI system or monitoring device to control timing of contrast injections; it is made entirely of non-ferromagnetically active materials for MRI compatiblity.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXT	Injector And Syringe, Angiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073592	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35e78a0d-a68b-44af-9281-c170e471de8c
Public Version Date: December 04, 2023
Public Version Number: 6
DI Record Publish Date: September 09, 2016