ADVANTA

GUDID 00650862210781

10MMX80CM, SW, H, ADVANTA VXT

ATRIUM MEDICAL CORPORATION

Synthetic vascular graft

• Primary Device ID: 00650862210781
• NIH Device Record Key: 6655c1f5-7018-46e2-94ec-5986e6ce2987
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANTA
• Version Model Number: 21078
• Company DUNS: 051798999
• Company Name: ATRIUM MEDICAL CORPORATION
• 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: false
• Serial Number: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650862210781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992960

FDA Product Code

• DSY: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [ADVANTA]

• 00650862212792: 5MMX10CM, SW, H, ADVANTA VXT
• 00650862212778: 5MMX10CM, SW, ADVANTA VXT
• 00650862212761: 4MMX10CM, SW, ADVANTA VXT
• 00650862211542: 6MMX10CM, TW, ADVANTA VXT
• 00650862210781: 10MMX80CM, SW, H, ADVANTA VXT
• 00650862210774: 8MMX80CM, SW, H, ADVANTA VXT
• 00650862210767: 7MMX80CM, SW, H, ADVANTA VXT
• 00650862210743: 5MMX80CM, SW, H, ADVANTA VXT
• 00650862210293: 10MMX70CM, SW, ADVANTA VXT
• 00650862210248: 4MMX70CM, SW, ADVANTA VXT
• 00650862210200: 10MMX50CM, SW, ADVANTA VXT
• 00650862210156: 4MMX50CM, SW, ADVANTA VXT
• 00650862210071: 6MMX30CM, SW, ADVANTA VXT
• 00650862210026: 8MMX10CM, SW, ADVANTA VXT
• 00650862210019: 7MMX10CM, SW, ADVANTA VXT
• 00650862210002: 6MMX10CM, SW, ADVANTA VXT