Fenwal Y-Type Blood Comp. Recipient Set with Std. 4C2161

GUDID 14052682004190

Y-Type Blood Component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path

Fresenius Kabi AG

Blood transfusion set

• Primary Device ID: 14052682004190
• NIH Device Record Key: df54ff23-302b-4972-8cee-062148d061b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fenwal Y-Type Blood Comp. Recipient Set with Std.
• Version Model Number: 4C2161
• Catalog Number: 4C2161
• Company DUNS: 315654579
• Company Name: Fresenius Kabi AG
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-933-6925
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052682004193 [Primary]
GS1	14052682004190 [Package]; Contains: 04052682004193; Package: Box [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073339

FDA Product Code

• BRZ: Set, Blood Transfusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-26

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