H. Lee SafeSheath® Sealing Adapter FCL-094-02

GUDID 10884450162139

Merit Medical

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• Primary Device ID: 10884450162139
• NIH Device Record Key: 752f92b7-a198-46eb-b090-6617c053f2ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H. Lee SafeSheath® Sealing Adapter
• Version Model Number: 00884450162132
• Catalog Number: FCL-094-02
• Company DUNS: 065673912
• Company Name: Merit Medical
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450162132 [Primary]
GS1	10884450162139 [Package]; Contains: 00884450162132; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• DTL: Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-02-01

On-Brand Devices [H. Lee SafeSheath® Sealing Adapter]

• 10884450162146: 00884450162149
• 10884450162139: 00884450162132
• 10884450162115: 00884450162118