Synergy-XS A14-04260-IR

GUDID 10876604004761

4F x 60 cm Dual Lumen Synergy-XS CT PICC IR Kit

Health Line International Corporation

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter

• Primary Device ID: 10876604004761
• NIH Device Record Key: fb1ea832-5bea-4a5f-9863-b61d39770c60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy-XS
• Version Model Number: A14-04260-IR-03
• Catalog Number: A14-04260-IR
• Company DUNS: 806251398
• Company Name: Health Line International Corporation
• 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	00876604004764 [Primary]
GS1	10876604004761 [Package]; Contains: 00876604004764; Package: Inner [5 Units]; In Commercial Distribution
GS1	20876604004768 [Package]; Package: Carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101329

FDA Product Code

• LJS: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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: 2023-06-01
• Device Publish Date: 2023-05-24

On-Brand Devices [Synergy-XS]

• 10876604004761: 4F x 60 cm Dual Lumen Synergy-XS CT PICC IR Kit
• 10876604004747: 3F x 60 cm Single Lumen Synergy-XS CT PICC IR Kit
• 10876604004686: 4F x 60 cm Dual Lumen Synergy-XS CT PICC Nursing Kit
• 10876604004679: 3F x 60 cm Single Lumen Synergy-XS CT PICC Nursing Kit
• 10876604004624: 4F x 60 cm Dual Lumen Synergy-XS CT PICC Basic Kit
• 10876604004600: 3Fr x 60cm Single Lumen Synergy-XS CT PICC Basic Kit