AMSure® Specimen Cup

Basic Information

• Brand Name: AMSure® Specimen Cup
• Primary DI: 10704411008415
• Version / Model: 1
• Catalog Number: AS345
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-05
• Public Version: 2
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: d913a6fc-a79d-4b7e-989c-ae7faa845562

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10943	Sputum specimen container IVD	A covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of a sputum specimen for culture, analysis, and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10704411008415	GS1
Package	40704411008416	GS1	case	100	In Commercial Distribution