AMSafe® Microbore Extension Set IVE2501

GUDID 40704411012185

AMSafe® Microbore Extension Set 100 inch long (254cm) CAUTION: Avoid freezing and excessive heat.

AMSINO INTERNATIONAL, INC.

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• Primary Device ID: 40704411012185
• NIH Device Record Key: d80f9555-19c2-4805-bc68-545e90962d03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe® Microbore Extension Set
• Version Model Number: 1
• Catalog Number: IVE2501
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 50
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00704411012187 [Unit of Use]
GS1	10704411012184 [Primary]
GS1	40704411012185 [Package]; Contains: 10704411012184; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093773

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2020-04-27
• Device Publish Date: 2020-04-17

Devices Manufactured by AMSINO INTERNATIONAL, INC.

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