Embedding® Tool TE-1000/A

GUDID 10884450170011

Merit Medical Systems, Inc.

Peritoneal dialysis catheter introduction set

• Primary Device ID: 10884450170011
• NIH Device Record Key: 5ca1c655-4128-4246-8d20-3dce6ec3e728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embedding® Tool
• Version Model Number: 00884450170014
• Catalog Number: TE-1000/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: false
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450170014 [Primary]
GS1	10884450170011 [Package]; Contains: 00884450170014; Package: [1 Units]; In Commercial Distribution
GS1	20884450170018 [Package]; Package: [30 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060897

FDA Product Code

• FJS: CATHETER, PERITONEAL, LONG-TERM INDWELLING

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: 2018-07-06
• Device Publish Date: 2015-10-30

Devices Manufactured by Merit Medical Systems, Inc.

• 10884450620639 - Aspira®: 2025-01-31
• 10884450788490 - Impress®: 2025-01-31
• 10884450836078 - Performa®: 2025-01-30
• 10884450859497 - Merit Medical®: 2025-01-30
• 20884450859883 - High Pressure Tubing: 2025-01-30
• 10884450860059 - Merit Medical®: 2025-01-30
• 00884450845455 - WRAPSODY®: 2025-01-29
• 00884450845707 - WRAPSODY®: 2025-01-29