FK20220E

GUDID 00850005864059

18” (46cm) Standard bore extension set with roller clamp, 1 needleless connector, male luer-lock and female luer

PATHEN MEDICAL LLC

Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 00850005864059
• NIH Device Record Key: a9463402-acc0-44ec-98c4-e5cf45d26a58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FK20220E
• Version Model Number: FK20220E
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850005864059 [Primary]
GS1	20850005864053 [Package]; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2019-03-29
• Device Publish Date: 2019-03-21

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: 2019-09-17 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