B.BRAUN

Basic Information

• Brand Name: B.BRAUN
• Primary DI: 04046964290145
• Version / Model: 4107
• Catalog Number: 4107
• Company Name: B.Braun Avitum AG
• Labeler DUNS: 343689704
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2017-01-18
• Public Version: 5
• Public Version Date: 2021-10-15
• Public Version Status: Update
• Public Device Record Key: ae10bb23-e0aa-4d0d-975f-e8f44ca45d56
• Distribution End Date: 2021-10-13

Device Description

HELP 0,9 % SODIUM CHLORIDE US 3000ML

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
MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
35913	Device-irrigation sterile saline solution	A sterile sodium chloride (NaCl) solution intended to be used for the cleaning and irrigation of a variety of devices that hold or conduct materials (e.g., a Foley catheter or a tracheobronchial suction catheter); it is not dedicated to a particular type of device. The solution is not intended for wound irrigation or injection or intravenous (IV) administration. It is usually available in a plastic container (e.g., 250 ml) or bottle of various sizes. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04046964290145	GS1
Unit of Use	04046964041594	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Concentration (IU/ml) : 0.009 IE3
Device Size Text, specify			Volume : 3000.000 ML
Device Size Text, specify			Concentration : 0.900 %

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius