primeMIDLINE PFM4SML20

GUDID 00813623011595

4F x 20cm Single Lumen CT Midline

PFM MEDICAL INCORPORATED

Central venous catheterization kit, short-term

• Primary Device ID: 00813623011595
• NIH Device Record Key: 97ea6bfa-d3f6-4ae1-b7f9-9cea1458dc6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primeMIDLINE
• Version Model Number: PFM4SML20
• Catalog Number: PFM4SML20
• Company DUNS: 097736867
• Company Name: PFM MEDICAL INCORPORATED
• 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

Customer Support Contacts

• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813623011595 [Primary]
GS1	10813623011592 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20813623011599 [Package]; Contains: 10813623011592; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173114

FDA Product Code

• PND: Midline Catheter

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: 2019-04-08
• Device Publish Date: 2019-03-31

On-Brand Devices [primeMIDLINE]

• 20813623011629: 5F (1.67mm) x 20cm Dual Lumen CT Midline
• 00813623011588: 3F (1.00mm) x 20cm Single Lumen CT Midline
• 20813623011605: 5F x 20cm Single Lumen CT Midline
• 00813623011595: 4F x 20cm Single Lumen CT Midline
• 20813623010158: 3F x 20cm Single Lumen CT Midline
• 20813623010141: 4F x 20cm Single Lumen CT Midline