primePICC PFM2CT4SL

GUDID 20813623013647

4F (1.33mm) x 50cm SINGLE LUMEN CT PICC OTW KIT

PFM MEDICAL INCORPORATED

Peripherally-inserted central venous catheter

• Primary Device ID: 20813623013647
• NIH Device Record Key: 7c46b236-73d5-4d4e-993a-7462ecf5e573
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primePICC
• Version Model Number: PFM2CT4SL
• Catalog Number: PFM2CT4SL
• 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
• 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	00813623013643 [Primary]
GS1	10813623013640 [Package]; Contains: 00813623013643; Package: [5 Units]; In Commercial Distribution
GS1	20813623013647 [Package]; Contains: 10813623013640; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083873

FDA Product Code

• LJS: Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-14
• Device Publish Date: 2017-01-19

On-Brand Devices [primePICC]

• 20813623013821: 6F (2.00mm) x 60cm TRIPLE LUMEN CT PICC OTW KIT
• 20813623013791: 5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC OTW KIT
• 20813623013760: 6F (2.00mm) x 60cm DUAL LUMEN CT PICC OTW KIT
• 20813623013739: 5F (1.67mm) x 55cm DUAL LUMEN CT PICC OTW KIT
• 20813623013708: 5F (1.67mm) x 55cm SINGLE LUMEN CT OTW WIRE KIT
• 20813623013647: 4F (1.33mm) x 50cm SINGLE LUMEN CT PICC OTW KIT
• 20813623013616: 3F (1.00mm) x 45cm SINGLE LUMEN CT PICC OTW KIT
• 20813623010189: 4F x 50cm Dual Lumen CT PICC Nursing Kit
• 20813623010172: 4F x 50cm Single Lumen CT PICC Nursing Kit
• 20813623010165: 3F x 45cm Single Lumen CT PICC Nursing Kit