Axiom® Dual-Sump

Basic Information

• Brand Name: Axiom® Dual-Sump
• Primary DI: M665111197SR0
• Version / Model: 111197SR
• Company Name: AXIOM MEDICAL, INCORPORATED
• Labeler DUNS: 094439676
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 7d35f617-7734-4641-b3f3-fe03d229f0c0

Device Description

Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring

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: No
• 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
FEG	Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15270	Sump drain	A sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M665111197SR3	HIBCC	Case	10	In Commercial Distribution
Package	M665111197SR1	HIBCC	Box	10	In Commercial Distribution
Primary	M665111197SR0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K771048	000

Device Sizes

Type	Value	Unit	Text
Length	14	Inch
Lumen/Inner Diameter	8.5	Millimeter