SteriPath Gen2, Luer, 20ml 2720-EN

GUDID 00858366007306

Steripath Blood Collection System, Sterile Pack, Luer, 20ml Syringe

Magnolia Medical Technologies, Inc.

Blood transfer set

• Primary Device ID: 00858366007306
• NIH Device Record Key: d2b51430-bd9a-4b57-a05b-9e5cd2c8cafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriPath Gen2, Luer, 20ml
• Version Model Number: 2720-EN
• Catalog Number: 2720-EN
• Company DUNS: 078603710
• Company Name: Magnolia Medical Technologies, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858366007245 [Primary]
GS1	00858366007306 [Package]; Contains: 00858366007245; Package: Sales Pack [10 Units]; In Commercial Distribution
GS1	00858366007559 [Package]; Package: Transport Pack [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192247

FDA Product Code

• JKA: Tubes, Vials, Systems, Serum Separators, Blood Collection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-27
• Device Publish Date: 2020-11-06

Devices Manufactured by Magnolia Medical Technologies, Inc.

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