AMDS Hybrid Prosthesis ("AMDS") AMDS5540

GUDID 00877234001222

55mm – 40mm Tapered Stent (32mm collar)

Artivion, Inc.

Bare-metal aortic stent

• Primary Device ID: 00877234001222
• NIH Device Record Key: c4da6f2b-6427-48dc-846f-aef45018c658
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMDS Hybrid Prosthesis ("AMDS")
• Version Model Number: K039423
• Catalog Number: AMDS5540
• Company DUNS: 119253177
• Company Name: Artivion, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com
• Phone: 1(888) 427-9654
• Email: customerservice.us@artivion.com

Device Dimensions

• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Catheter Length: 546 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00877234001222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H230007

FDA Product Code

• QSK: Hybrid Stent Graft, Thoracic Aortic Lesion Treatment

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: 2025-02-13
• Device Publish Date: 2025-02-05

On-Brand Devices [AMDS Hybrid Prosthesis ("AMDS")]

• 00877234001338: 40mm (Classic) Straight Stent (28mm collar)
• 00877234001321: 40mm – 30mm (Classic) Tapered Stent (28mm collar)
• 00877234001222: 55mm – 40mm Tapered Stent (32mm collar)
• 00877234001215: 55mm Straight Stent (32mm collar)
• 00877234001208: 40mm – 30mm Tapered Stent (24mm collar)
• 00877234001192: 40mm Straight Stent (24mm collar)