Synergy XS

GUDID 20876604001231

4Fr x 60cm Double Lumen Synergy XS CT PICC Basic Kit for US

Health Line International Corporation

Peripherally-inserted central venous catheter

• Primary Device ID: 20876604001231
• NIH Device Record Key: 870f3b02-10de-4583-ad65-db687dfd5db2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy XS
• Version Model Number: A14-04260-US
• 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	00876604001237 [Primary]
GS1	10876604001234 [Package]; Contains: 00876604001237; Package: Inner [5 Units]; In Commercial Distribution
GS1	20876604001231 [Package]; Contains: 10876604001234; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-21
• Device Publish Date: 2016-11-17

On-Brand Devices [Synergy XS]

• 20876604001248: 3Fr x 60cm Single Lumen Synergy XS CT PICC IR Kit for US
• 20876604001231: 4Fr x 60cm Double Lumen Synergy XS CT PICC Basic Kit for US
• 20876604001224: 3Fr x 60cm Single Lumen Synergy XS CT PICC Basic Kit for US
• 20876604000913: 4Fr x 60cm Dual Lumen Synergy-XS CT PICC IR Kit
• 00876604000674: 4Fr x 60 cm Dual Lumen Synergy XS CT PICC Nursing Kit
• 00876604000629: 3Fr x 60cm Single Lumen Synergy XS CT PICC Nursing Kit
• 10876604000879: 3Fr x 60cm Single Lumen Synergy XS CT PICC IR Kit
• 10876604000282: 3Fr x 60cm Single Lumen Synergy XS CT PICC Basic Kit