Salem Sump

Basic Information

• Brand Name: Salem Sump
• Primary DI: 10884521020108
• Version / Model: 8888265140
• Catalog Number: 8888265140
• Company Name: Cardinal Health, Inc.
• Labeler DUNS: 080935429
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2019-02-15
• Public Version Status: Update
• Public Device Record Key: b4906a6a-a0a3-4e48-99af-d78aa0cc5db3

Device Description

Silicone Dual Lumen Stomach Tube,Radiopaque Line

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
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35415	Nasogastric decompression tube	A sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. It may also be used for the delivery of fluids (for irrigation, enteral feeding, and medication administration) typically for the period that gastric decompression is required. This device may be referred to as a nasogastric sump tube or a gastrointestinal decompression tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521020105	GS1	CASE	10	In Commercial Distribution
Primary	10884521020108	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K830710	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry;AVOID DIRECT SUNLIGHT