RAPIDTRANSIT 601210

GUDID 10886704028314

RAPIDTRANSIT Infusion Catheter Outer Diameter (Distal) 2.3F (0.75 mm) Usable Length 70 cm 2.8F (0.95 mm) .021 Inch (0.5 mm) 30cm Contents: 1 Infusion Catheter and 1 Shape Mandrel. Minimum Guiding Catheter I.D. / Dia. .042 Inch (1.1 mm)

Medos International Sàrl

Vascular microcatheter

• Primary Device ID: 10886704028314
• NIH Device Record Key: ac22e35a-2616-45ff-bb43-bbb059f13e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPIDTRANSIT
• Version Model Number: 601-210
• Catalog Number: 601210
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DARK, DRY PLACE

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704028314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972518

FDA Product Code

• KRA: Catheter, continuous flush

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-29
• Device Publish Date: 2016-06-30

On-Brand Devices [RAPIDTRANSIT]

• 10886704028369: RAPIDTRANSIT Infusion Catheter Outer Diameter (Distal) 2.3F (0.75 mm) Usable Length 170 cm 2.8F
• 10886704028352: RAPIDTRANSIT Infusion Catheter with 2 Markers Infusion Catheter Outer Diameter (Distal) 2.3F (0.
• 10886704028345: RAPIDTRANSIT Infusion Catheter Outer Diameter (Distal) 2.3F (0.75 mm) Usable Length 150 cm 2.8F
• 10886704028314: RAPIDTRANSIT Infusion Catheter Outer Diameter (Distal) 2.3F (0.75 mm) Usable Length 70 cm 2.8F (
• 10886704028338: RAPIDTRANSIT Infusion Catheter TIP MARKERS 1 USABLE LENGTH 100 cm DISTAL LENGTH 30 cm DISTAL OD
• 10886704028321: RAPIDTRANSIT Infusion Catheter TIP MARKERS 1 USABLE LENGTH 135 cm DISTAL LENGTH 50 cm DISTAL OD