AMSure® Coiled Suction Catheter

Basic Information

• Brand Name: AMSure® Coiled Suction Catheter
• Primary DI: 10704411010036
• Version / Model: 1
• Catalog Number: AS360C
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-05
• Public Version: 1
• Public Version Date: 2018-11-05
• Public Version Status: New
• Public Device Record Key: b3a3a515-2cd8-4e3e-a9c5-79ba761fa2f6

Device Description

AMSure® Coiled Suction Catheter SIZE:5Fr.

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	50704411010034	GS1	master carton	20	In Commercial Distribution
Package	40704411010037	GS1	case	50	In Commercial Distribution
Primary	10704411010036	GS1