AccessGUDID - DEVICE: Ivenix Infusion System (00811050530399)

GUDID

Device Identifier (DI) Information

Brand Name: Ivenix Infusion System
Version or Model: 030-0027-05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: IMS
Company Name: Fresenius Kabi AG

Primary DI Number: 00811050530399
Issuing Agency: GS1
Commercial Distribution End Date: July 19, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: Infusion Management System (IMS)

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):	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?
47903	Infusion pump medication-dosage application software	A software program intended to enable a healthcare professional to create, modify and store (manage) dosage parameters (protocols) for delivery of medication by an electronic infusion pump(s) or a syringe pump(s) which is used in a hospital/institution (e.g., IV pole mounted) or used for ambulatory purposes [also known as computerized ambulatory drug delivery (CADD)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHC	Infusion Safety Management Software

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K183311	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: 32f809d2-4ef5-4956-846a-bab0b67ec053
Public Version Date: August 21, 2023
Public Version Number: 3
DI Record Publish Date: April 07, 2023