AMSure® Suction Catheter Kit

Basic Information

• Brand Name: AMSure® Suction Catheter Kit
• Primary DI: 10704411008583
• Version / Model: 1
• Catalog Number: AS375
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-12
• Public Version: 1
• Public Version Date: 2018-07-13
• Public Version Status: New
• Public Device Record Key: 8c9917cc-91d7-49ba-b867-6b6ef76379a5

Device Description

AMSure® Suction Catheter Kit SIZE: 14Fr. CONTENTS: 1 ea Catheter 1 ea Vinyl Glove 1 ea Pop-up Cup

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: Yes
• 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
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	868.6810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411008584	GS1	case	50	In Commercial Distribution
Primary	10704411008583	GS1