SteriPath Gen2, Luer 2700-EN

GUDID 10858366007006

Steripath Blood Collection System, Sterile Pack, Luer, Wide Neck TA

Magnolia Medical Technologies, Inc.

Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set Blood transfer set

• Primary Device ID: 10858366007006
• NIH Device Record Key: 1c49b1f6-5c69-4d2e-9106-47ff2a4d304f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriPath Gen2, Luer
• Version Model Number: 2700-EN
• Catalog Number: 2700-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	00858366007009 [Primary]
GS1	00858366007474 [Package]; Package: Transport Pack [10 Units]; In Commercial Distribution
GS1	10858366007006 [Package]; Contains: 00858366007009; Package: Sales 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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• 10858366007136 - Steripath: 2024-04-08 Steripath Blood Collection System, Sterile Pack, 21G UltraTouch, Long Neck TA
• 10858366007143 - Steripath: 2024-04-08 Steripath Blood Collection System, Sterile Pack, 23G UltraTouch, Long Neck TA
• 10858366007167 - Steripath: 2024-04-08 Steripath Blood Collection System, Sterile Pack, 23G UltraTouch, 10ml Syringe
• 10858366007174 - Steripath: 2024-04-08 Steripath Blood Collection System, Sterile Pack, 21G UltraTouch, 20ml Syringe
• 10858366007334 - Steripath Micro: 2024-03-29 Steripath Micro, 21G UltraTouch, Wide Neck TA
• 10858366007365 - Steripath Micro: 2024-03-29 Steripath Micro, 21G UltraTouch, Long Neck TA