BMS-2135.17S

GUDID 10850005864605

Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock,

PATHEN MEDICAL LLC

Peripheral vascular/subcutaneous catheter

• Primary Device ID: 10850005864605
• NIH Device Record Key: 10961b61-8b8b-433e-9341-f75c475b4fa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMS-2135.17S
• Version Model Number: BMS-2135.17S
• Company DUNS: 042928915
• Company Name: PATHEN MEDICAL LLC
• 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: false
• 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: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com
• Phone: 8773185421
• Email: questions@pathen.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005864608 [Primary]
GS1	10850005864605 [Package]; Contains: 00850005864608; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161779

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less 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: 2019-09-17
• Device Publish Date: 2019-09-09

Devices Manufactured by PATHEN MEDICAL LLC

• 20850005864640 - PS-84320: 2019-11-18 20G X 1.88" IV CATHETER PURSAFETY S
• 20850005864619 - PS-843242: 2019-11-13 24GX .56" IV CATHETER PURSAFETY S
• 20850005864626 - PS-84326: 2019-11-13 26GX 56" IV CATHETER PURSAFETY S
• 20850005864633 - PS-843262: 2019-11-13 26GX.75" IV CATHETER PURSAFETY S
• 00850005864561 - BASNWS -30/150: 2019-09-24 Administration Set, NO Spike, 150 Micron Filter, 30cc Syringe
• 10850005864605 - BMS-2135.17S: 2019-09-17Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock,
• 10850005864605 - BMS-2135.17S: 2019-09-17 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock,
• 10850005864575 - BM-2135.17: 2019-09-13 Adminstration Set, Female Luer Lock, 150 Micron Filter w/ Male Luer Lock
• 10850005864582 - 002231: 2019-09-13 Extension Set, 6" w/ 3-way stopcock