AccessGUDID - DEVICE: AGILIA LINK 8 US (04086000856720)

GUDID

Device Identifier (DI) Information

Brand Name: AGILIA LINK 8 US
Version or Model: Z078135
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z078135
Company Name: Fresenius Kabi AG

Primary DI Number: 04086000856720
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315654579 *Terms of Use

Device Description: Agilia Link 8 is an accessory to Agilia Infusion System as the stacking rack system intended to power and organize eight Agilia infusion pumps at the patient bedside. The Agilia Infusion System includes the Agilia Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with disposables and optional accessories.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
42498	Intravenous pole multi-outlet holder	A mains electricity (AC-powered) device used with an intravenous (IV) pole (usually of the floor-standing type) and designed to provide multiple electrical outlet sockets so that an electrical source is made available when two or more infusion pumps are mounted into the retaining slots provided. This device will fit onto a standard IV pole and is intended to accept the mounting of a number of infusion pumps, keeping them safely fastened to the pole in an organized manner.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MRZ	Accessories, Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K210073	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: 7f49de6f-6a0b-42ca-b21c-4f6c3b56c4b3
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022