Tenzing 7 Delivery Catheter, Single Pack REF 7001-T71-151

GUDID 00853799007978

Tenzing 7 Delivery Catheter - Single Pack; Contains Tenzing 7 Delivery Catheter (00853799007541)

ROUTE 92 MEDICAL

Vascular microcatheter

• Primary Device ID: 00853799007978
• NIH Device Record Key: 60ee95bc-2558-41f7-bfad-d8b40679aeed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenzing 7 Delivery Catheter, Single Pack
• Version Model Number: Gen 1
• Catalog Number: REF 7001-T71-151
• 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: 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007978 [Primary]

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: 2025-08-05
• Device Publish Date: 2025-07-28

Devices Manufactured by ROUTE 92 MEDICAL

• 00853799007978 - Tenzing 7 Delivery Catheter, Single Pack: 2025-08-05Tenzing 7 Delivery Catheter - Single Pack; Contains Tenzing 7 Delivery Catheter (00853799007541)
• 00853799007978 - Tenzing 7 Delivery Catheter, Single Pack: 2025-08-05 Tenzing 7 Delivery Catheter - Single Pack; Contains Tenzing 7 Delivery Catheter (00853799007541)
• 00853799007985 - Tenzing 7 Delivery Catheter, 2-pack: 2025-08-05 Tenzing 7 Delivery Catheter, 2-pack; Contains 2x of Tenzing 7 Delivery Catheter (00853799007541)
• 00853799007701 - 8F Base Camp system 2.0 80cm: 2024-10-22 8F Base Camp system 2.0 80cm
• 00853799007718 - 8F Base Camp system 2.0 80cm: 2024-10-22 8F Base Camp system 2.0 80cm; Contains 8F Base Camp system 2.0 80cm (00853799007701)
• 00853799007725 - 8F Base Camp system 2.0 90cm: 2024-10-22 8F Base Camp system 2.0 90cm
• 00853799007732 - 8F Base Camp system 2.0 90cm: 2024-10-22 8F Base Camp system 2.0 90cm; 8F Base Camp system 2.0 90cm (00853799007725)
• 00853799007749 - FreeClimb 88 catheter, 125cm: 2024-07-09 FreeClimb 88 catheter, 125cm
• 00853799007756 - FreeClimb 88 catheter, 132cm: 2024-07-09 FreeClimb 88 catheter, 132cm