Triple Lumen PFM PICC PFM2CT5TL

GUDID 00813623018075

5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC LONG WIRE KIT

PFM MEDICAL INCORPORATED

Peripherally-inserted central venous catheter Peripherally-inserted central venous catheter

• Primary Device ID: 00813623018075
• NIH Device Record Key: 859ec573-a865-4703-b68e-b5b41d1eb58e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triple Lumen PFM PICC
• Version Model Number: PFM2CT5TL
• Catalog Number: PFM2CT5TL
• Company DUNS: 097736867
• Company Name: PFM MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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.
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813623018075 [Primary]
GS1	10813623018072 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20813623018079 [Package]; Contains: 10813623018072; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110914

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-09

On-Brand Devices [ Triple Lumen PFM PICC]

• 20813623040582: 5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC
• 20813623018598: 6F (2.00mm) x 60cm TRIPLE LUMEN CT PICC
• 20813623018093: 6F (2.00mm) x 60cm TRIPLE LUMEN CT PICC NURSING KIT
• 20813623018086: 5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC NURSING KIT
• 00813623018075: 5F (1.67mm) x 55cm TRIPLE LUMEN CT PICC LONG WIRE KIT
• 20813623017447: 6F (2.00mm) x 60cm TRIPLE LUMEN CT PICC LONG WIRE KIT