MediBag

Basic Information

• Brand Name: MediBag
• Primary DI: 00857595005114
• Version / Model: 220121
• Catalog Number: 220121
• Company Name: SUMMIT MEDICAL PRODUCTS, INC.
• Labeler DUNS: 831704841
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 6
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: 687601b0-c708-475d-a499-0478bbff2f8f

Device Description

MediBag - 250 mL

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: 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
KPE	Container, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35188	Parenteral/enteral solution bag	A flexible pouch or sack designed to contain a solution of nutrients or medication for administration to a patient either parenterally (e.g., intravenously) or enterally (directly into the gastrointestinal tract). It is typically made of synthetic polymer materials. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20857595005118	GS1		60	In Commercial Distribution
Package	10857595005111	GS1		30	In Commercial Distribution
Primary	00857595005114	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001287	000

Device Sizes

Type	Value	Unit	Text
Total Volume	250	Milliliter