Synergy

GUDID 20876604000944

6FR X 60 Dual Lumen Synergy CT PICC IR Kit

Health Line International Corporation

Peripherally-inserted central venous catheter

• Primary Device ID: 20876604000944
• NIH Device Record Key: fccc7090-fabe-4722-9873-ea176ab09d27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Synergy
• Version Model Number: KIT-405-62
• 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	00876604000940 [Primary]
GS1	10876604000947 [Package]; Contains: 00876604000940; Package: Inner [5 Units]; In Commercial Distribution
GS1	20876604000944 [Package]; Contains: 10876604000947; 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: 2016-03-31

On-Brand Devices [Synergy]

• 20876604001194: 5FR X 60cm Single Lumen Synergy CT PICC IR Kit
• 20876604001187: 5Fr x 60cm Dual Lumen Synergy CT PICC Basic Kit
• 20876604001170: 5Fr x 55cm Dual Lumen Synergy CT PICC IR Kit
• 20876604001156: 5Fr x 60cm Single Lumen Synergy CT PICC IR Kit
• 20876604001149: 5Fr x 55cm Single Lumen Synergy CT PICC IR Kit
• 20876604001132: 4Fr x 60cm Single Lumen Synergy CT PICC Basic Kit
• 20876604001101: 5Fr x 60cm Single Lumen Synergy CT PICC Basic Kit
• 10876604001081: 5Fr x 55cm Single Lumen Synergy CT PICC Nursing Kit
• 00876604001053: 4Fr x 50cm Single Lumen Synergy CT PICC IR Kit
• 20876604001019: 6FR x 60cm Triple Lumen Synergy CT PICC Nursing Kit
• 20876604001002: 6FR x 60cm Dual Lumen Synergy CT PICC Nursing Kit
• 20876604000999: 6FR x 60cm Dual Lumen Synergy CT PICC Nursing Kit
• 20876604000968: 6FR x 60cm Triple Lumen Synergy CT PICC IR Kit
• 20876604000951: 6FR x 60cm Triple Lumen Synergy CT PICC IR Kit
• 20876604000944: 6FR X 60 Dual Lumen Synergy CT PICC IR Kit
• 20876604000937: 6FR X 60 Dual Lumen Synergy CT PICC IR Kit
• 20876604000906: 4FR X 60cm Single Lumen Synergy CT PICC IR Kit
• 20876604000890: 4FR X 50cm Single Lumen Synergy CT PICC IR Kit
• 20876604000869: 6FR x 60cm Triple Lumen Synergy CT PICC Basic Kit
• 20876604000852: 6FR x 60cm Triple Lumen Synergy CT PICC Basic Kit
• 20876604000845: 60FR X 60cm Dual Lumen Synergy CT PICC Basic Kit
• 20876604000838: 60FR X 60cm Dual Lumen Synergy CT PICC Basic Kit
• 20876604000821: 5Fr x 55cm Dual Lumen Synergy CT PICC Basic Kit
• 20876604000814: 5Fr x 55cm Single Lumen Synergy CT PICC Basic Kit
• 20876604000784: 4FR x 50cm Single Lumen Synergy CT PICC Basic Kit
• 20876604000777: 4FR x 50cm Single Lumen Synergy CT PICC Basic Kit
• 00876604000711: 5Fr x 60cm Dual Lumen Synergy CT Nursing Kit
• 00876604000704: 5Fr x 60cm Dual Lumen Synergy CT Nursing Kit
• 00876604000698: 5Fr x 60cm Single Lumen Synergy CT PICC Nursing Kit
• 00876604000681: 5Fr x 60cm Single Lumen Synergy CT PICC Nursing Kit
• 00876604000643: 4Fr x 60cm Single Lumen Synergy CT PICC Nursing Kit
• 00876604000636: 4Fr x 60cm Single Lumen Synergy CT PICC Nursing Kit
• 00876604000612: 5Fr x 60cm Dual Lumen Synergy CT PICC IR Kit
• 00876604000605: 5Fr x 60cm Dual Lumen Synergy CT PICC IR Kit
• 00876604000599: 5Fr x 55cm Dual Lumen Synergy CT PICC Basic Kit
• 00876604000582: 5Fr x 55cm Single Lumen Synergy CT PICC Basic Kit
• 10876604001166: 5Fr x 55cm Dual Lumen Synergy CT PICC Nursing Kit
• 10876604000794: 4Fr x 60cm Double Lumen Synergy CT PICC Basic Kit
• 10876604004808: 6F x 60 cm Triple Lumen Synergy CT PICC IR Kit
• 10876604004792: 6F x 60 cm Dual Lumen Synergy CT PICC IR Kit
• 10876604004785: 5F x 60 cm Dual Lumen Synergy CT PICC IR Kit
• 00876604004771: 5F x 60 cm Single Lumen Synergy CT PICC IR Kit
• 10876604004754: 4F x 60 cm Single Lumen Synergy CT PICC IR Kit
• 10876604004730: 4F x 60 cm Single Lumen Synergy CT PICC Nursing Kit
• 10876604004723: 5F x 60 cm Dual Lumen Synergy CT PICC Nursing Kit
• 10876604004716: 6F x 60 cm Triple Lumen Synergy CT PICC Nursing Kit
• 10876604004709: 6F x 60 cm Dual Lumen Synergy CT PICC Nursing Kit
• 10876604004693: 5F x 60 cm Single Lumen Synergy CT PICC Nursing Kit
• 10876604004662: 6F x 60 cm Triple Lumen Synergy CT PICC Basic Kit
• 10876604004655: 6F x 60 cm Dual Lumen Synergy CT PICC Basic Kit