B.BRAUN

Basic Information

• Brand Name: B.BRAUN
• Primary DI: 04046964187773
• Version / Model: S9901-10
• Catalog Number: S9901-10
• Company Name: B. BRAUN MEDICAL INC.
• Labeler DUNS: 002397347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a0215218-c9cb-4373-96b7-8c8425c52cd6

Device Description

Evacuated IV Container, Glass, 500 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: 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
KPE	CONTAINER, I.V.	General Hospital	880.5025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15808	Evacuated intravenous fluid container	A receptacle with a relative vacuum in its interior designed to be filled with intravenous (IV) fluids. It is typically an empty, pre-sealed container (e.g., glass bottles) with appropriate shape and size (usually in a range from 250 to 2000 ml) for IV solutions. It is mainly intended to facilitate filling by intravenous fluid compounders; it is typically used in clinical pharmacies and/or other healthcare departments and facilities. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964187773	GS1
Unit of Use	04046964187766	GS1

Customer Contacts

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