8F Base Camp system 2.0 80cm REF 5001-2-80B

GUDID 00853799007701

8F Base Camp system 2.0 80cm

ROUTE 92 MEDICAL

Vascular microcatheter

• Primary Device ID: 00853799007701
• NIH Device Record Key: 9f4f1281-d467-45d9-917f-c3668eb47044
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 8F Base Camp system 2.0 80cm
• Version Model Number: Gen 2.0
• Catalog Number: REF 5001-2-80B
• Company DUNS: 067429673
• Company Name: ROUTE 92 MEDICAL
• 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: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240529

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [8F Base Camp system 2.0 80cm]

• 00853799007718: 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701)
• 00853799007701: 8F Base Camp system 2.0 80cm