NRG Large Access Solution

GUDID 00685447018421

1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip Guidewire); 1 x ProTrack Pigtail Wire

Baylis Médicale Cie Inc

Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set Cardiac transseptal access set

• Primary Device ID: 00685447018421
• NIH Device Record Key: 5b0401a1-4edc-4256-a242-a3ec604fddc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NRG Large Access Solution
• Version Model Number: NLK71-C0-125-67-18
• Company DUNS: 249225954
• Company Name: Baylis Médicale Cie 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com
• Phone: 5144889801
• Email: info@baylismedical.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00685447018421 [Primary]

FDA Product Code

• DXF: Catheter, Septostomy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [NRG Large Access Solution]

• 00685447004837: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447004820: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447004813: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447004806: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447004790: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447004783: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447005872: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447005865: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447005858: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447005841: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447005834: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447005827: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015352: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015345: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015338: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015321: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015314: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015307: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015291: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015284: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015277: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015260: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015253: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447015246: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447018469: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447018452: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447018445: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447018438: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447018421: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip
• 00685447018414: 1 x NRG Transseptal Needle; 1 x ExpanSure Large Access Transseptal Dilator (including 1 x J-tip