088 Access System REF 2004

GUDID 00853799007275

088 Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 Catheter (00853799007282)

ROUTE 92 MEDICAL

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00853799007275
• NIH Device Record Key: 91e5c209-053b-4585-8be1-be3f35548c88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 088 Access System
• Version Model Number: FD 0456
• Catalog Number: REF 2004
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007275 [Primary]

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-08
• Device Publish Date: 2020-09-18

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: 2021-11-08088 Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and 088 Catheter (00853799007282)
• 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