PFM CT PICC II PFM2CT3S

GUDID 00813623040649

3F (1.00mm) x 45cm SINGLE LUMEN CT PICC

PFM MEDICAL INCORPORATED

Peripherally-inserted central venous catheter

• Primary Device ID: 00813623040649
• NIH Device Record Key: 1fc8825c-d19d-406b-9dfb-33abc087ace9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PFM CT PICC II
• Version Model Number: PFM2CT3S
• Catalog Number: PFM2CT3S
• 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	00813623040649 [Primary]
GS1	10813623040646 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	20813623040643 [Package]; Contains: 10813623040646; Package: [20 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-09

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