Tenzing 7 Delivery Catheter REF 1005

GUDID 00853799007237

Tenzing 7 Delivery Catheter

ROUTE 92 MEDICAL

Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter Vascular microcatheter

• Primary Device ID: 00853799007237
• NIH Device Record Key: f7b6776c-d362-4877-b2a5-5de6edac607f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenzing 7 Delivery Catheter
• Version Model Number: FD 0475
• Catalog Number: REF 1005
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007237 [Primary]
GS1	00853799007244 [Package]; Package: Shelf Carton [1 Units]; In Commercial Distribution
GS1	00853799007442 [Package]; Package: Shelf-Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190431

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: 2020-09-25
• Device Publish Date: 2020-09-17

Devices Manufactured by ROUTE 92 MEDICAL

• 00853799007619 - Tenzing 5: 2023-10-24 Tenzing 5 Delivery Catheter
• 00853799007640 - FreeClimb 54, 148cm: 2023-10-24 FreeClimb 54 Catheter, 148cm
• 00853799007657 - FreeClimb 54, 125cm: 2023-10-24 FreeClimb 54 Catheter, 125cm
• 00853799007183 - FreeClimb 70: 2023-05-03 Full Length 070 Catheter
• 00853799007060 - Full Length 088 Catheter, 132 cm: 2022-06-30 Full Length 088 Catheter, 132 cm
• 00853799007138 - Full Length 088 x 132cm Access System: 2022-06-30 Full Length 088 x 132cm Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and Full Length 088 Catheter, 132cm
• 00853799007275 - 088 Access System: 2021-11-08 088 Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 Catheter (00853799007282)
• 00853799007282 - 088 Catheter: 2021-11-08 088 Catheter