Tenzing 5

GUDID 00853799007619

Tenzing 5 Delivery Catheter

ROUTE 92 MEDICAL

Thrombectomy suction catheter

• Primary Device ID: 00853799007619
• NIH Device Record Key: d2215f62-77b7-474e-8647-2bc6bb5c2e04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenzing 5
• Version Model Number: SA 2222
• Company DUNS: 067429673
• Company Name: ROUTE 92 MEDICAL
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231583

FDA Product Code

• NRY: Catheter, Thrombus Retriever
• QJP: Catheter, Percutaneous, Neurovasculature

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: 2023-10-24
• Device Publish Date: 2023-10-16

Devices Manufactured by ROUTE 92 MEDICAL

• 00853799007749 - FreeClimb 88 catheter, 125cm: 2024-07-09 FreeClimb 88 catheter, 125cm
• 00853799007756 - FreeClimb 88 catheter, 132cm: 2024-07-09 FreeClimb 88 catheter, 132cm
• 00853799007763 - FreeClimb 88 catheter, 125cm with Tenzing 8: 2024-07-09 FreeClimb 88 catheter, 125cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 12
• 00853799007770 - FreeClimb 88 catheter, 132cm with Tenzing 8: 2024-07-09 FreeClimb 88 catheter, 132cm with Tenzing 8; Contains Tenzing 8 Delivery Catheter (00853799007299) and FreeClimb 88 catheter, 13
• 00853799007787 - FreeClimb 54 reperfusion catheter, 148cm: 2024-07-05 FreeClimb 54 reperfusion catheter, 148cm
• 00853799007794 - FreeClimb 54 reperfusion catheter, 125cm: 2024-07-05 FreeClimb 54 reperfusion catheter, 125cm
• 00853799007688 - FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5: 2024-06-07 FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5: Contains Tenzing 5 delivery Catheter (00853799007619) and FreeClimb 54
• 00853799007695 - FreeClimb 54 reperfusion catheter, 125cm with Tenzing 5: 2024-06-07 FreeClimb 54 reperfusion catheter, 125cm with Tenzing 5: Contains Tenzing 5 delivery catheter (00853799007619) and FreeClimb 54