AMSure® Specimen Container AS341

GUDID 10704411008392

AMSure® Specimen Container CONTENT: Non-Toxic4 oz./120cc with Tamper Evident Label

AMSINO INTERNATIONAL, INC.

Sputum specimen container IVD

• Primary Device ID: 10704411008392
• NIH Device Record Key: 46202281-711b-4e89-8a04-215acaad1ab5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure® Specimen Container
• Version Model Number: 1
• Catalog Number: AS341
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• Device Count: 100
• 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	10704411008392 [Primary]
GS1	40704411008393 [Unit of Use]

FDA Product Code

• FMH: Container, Specimen, 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

On-Brand Devices [AMSure® Specimen Container]

• 10704411010012: AMSure® Specimen Container Non-Toxic 4 oz./120cc CAUTION:Avoid freezing and excessive heat.
• 10704411008392: AMSure® Specimen Container CONTENT: Non-Toxic4 oz./120cc with Tamper Evident Label