K-Zero® M79400849

GUDID 04250273735949

The K-Zero Neutral Needleless Connector is intended for single patient use in intravenous and blood administration and aspiration without the need for needles, thus eliminating the potential for needle-stick injuries during use. The K-Zero Neutral Needleless Connector may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The subject device does ot have to be changed subsequent to use with a low pressure power injector.

Fresenius Kabi AG

Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use Electric infusion pump administration set, single-use

• Primary Device ID: 04250273735949
• NIH Device Record Key: d55101a6-e69a-460d-9d42-f09bb5fc6413
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-Zero®
• Version Model Number: Needleless Connector
• Catalog Number: M79400849
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com
• Phone: +496621168400
• Email: heinrich.martens@fresenius-kabi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250273735949 [Primary]
GS1	04250273735956 [Package]; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162826

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: 2022-12-08
• Device Publish Date: 2022-11-30

Devices Manufactured by Fresenius Kabi AG

• 00810020440591 - AMICUS Separator Legacy Software: 2024-04-04 Software version for AMICUS Separator Legacy Device
• 00810020440607 - AMICUS Separator Life Extension Software: 2024-04-04 Software version for AMICUS Separator Life Extension Device
• 04250273750164 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750218 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750287 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 04250273750294 - Volumat™ Line: 2024-03-29 IV administration set for infusion pumps
• 10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
• 10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual: 2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F