H. Lee SafeSheath® Sealing Adapter SS-SA-09

GUDID 10884450505363

Merit Medical Systems, Inc.

Haemostasis valve

• Primary Device ID: 10884450505363
• NIH Device Record Key: 165287f2-2b9f-432c-835a-2ec96ac8cf2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H. Lee SafeSheath® Sealing Adapter
• Version Model Number: 00884450505366
• Catalog Number: SS-SA-09
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450505366 [Primary]
GS1	10884450505363 [Package]; Contains: 00884450505366; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-21
• Device Publish Date: 2021-10-13

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

• 10884450505387: 00884450505380
• 10884450505363: 00884450505366
• 10884450505370: 00884450505373