NRG Large Access Solution

GUDID 00685447018445

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

Baylis Médicale Cie Inc

Cardiac transseptal access set

• Primary Device ID: 00685447018445
• NIH Device Record Key: 5cf2f9e3-f5d5-4515-8219-3f09a811b78d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NRG Large Access Solution
• Version Model Number: NLK71-C1-125-67
• 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	00685447018445 [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