AMSure® Specimen Cup AS345

GUDID 10704411008415

AMSure® Specimen Cup CONTENTS: 4 oz Graduated Cup with Screw Cap

AMSINO INTERNATIONAL, INC.

Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD Sputum specimen container IVD

• Primary Device ID: 10704411008415
• NIH Device Record Key: d913a6fc-a79d-4b7e-989c-ae7faa845562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Specimen Cup
• Version Model Number: 1
• Catalog Number: AS345
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411008415 [Primary]
GS1	40704411008416 [Package]; Package: case [100 Units]; In Commercial Distribution

FDA Product Code

• NNI: Container, Specimen, Non-Sterile

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: 2021-01-22
• Device Publish Date: 2018-06-05

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