Low Profile Peripheral

GUDID 07640110981771

Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter

PFM MEDICAL INCORPORATED

Vascular port/catheter

• Primary Device ID: 07640110981771
• NIH Device Record Key: de5d14c0-4ab0-4e3d-af60-f30995920bff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Low Profile Peripheral
• Version Model Number: 616.460.7080-A
• 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: regulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640110981771 [Package]; Contains: 07640110987742; Package: Box [20 Units]; In Commercial Distribution
GS1	07640110987742 [Primary]

FDA Product Code

• LJT: Port & Catheter, Implanted, Subcutaneous, 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: 2020-03-06
• Device Publish Date: 2020-02-27

On-Brand Devices [Low Profile Peripheral]

• 76401109877426: Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter
• 76401109877280: Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter
• 76401109877044: Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter
• 07640110981771: Low Profile Peripheral Silicone Kit with 8.4F x 750 mm Attachable Silicone Catheter
• 07640110981207: Low Profile Peripheral PUR Kit with 4.8F x 750 mm Attachable Polyurethane Catheter
• 07640110981764: Low Profile Peripheral Silicone Kit with 6.6F x 750 mm Attachable Silicone Catheter