Ivenix SET-0030-1

GUDID 00811505030160

LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1)

IVENIX, INC.

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• Primary Device ID: 00811505030160
• NIH Device Record Key: d097bbfa-8792-4eec-8031-3c120399641b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ivenix
• Version Model Number: SET-0030-1
• Catalog Number: SET-0030-1
• Company DUNS: 939332289
• Company Name: IVENIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com
• Phone: 978-775-8100
• Email: support@fresenius-kabi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811505030160 [Primary]
GS1	10811505030167 [Package]; Package: Shipper [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213089

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-12
• Device Publish Date: 2023-05-04

Devices Manufactured by IVENIX, INC.

• 00811505030436 - Ivenix Infusion System: 2023-08-15 Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030443 - Ivenix Infusion System: 2023-08-15 Infusion Management System (IMS)
• 00811505030375 - Ivenix Infusion System: 2023-07-27 Large Volume Pump (LVP) Software (order 1 per pump)
• 00811505030399 - Ivenix Infusion System: 2023-07-27 Infusion Management System (IMS)
• 00811505030160 - Ivenix: 2023-05-12LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1)
• 00811505030160 - Ivenix: 2023-05-12 LVP Epidural Administration Set, Single-Inlet, Low-Sorbing, Microbore, NRFit Connector (Qty 1)
• 00811050530375 - Ivenix Infusion System: 2023-04-17 Large Volume Pump (LVP) Software (order 1 per pump)
• 00811050530399 - Ivenix Infusion System: 2023-04-17 Infusion Management System (IMS)
• 00811505030320 - Ivenix Infusion System: 2022-09-15 Large Volume Pump (LVP)