B.BRAUN

Basic Information

• Brand Name: B.BRAUN
• Primary DI: 04046964290152
• Version / Model: 4109
• Catalog Number: 4109
• Company Name: B.Braun Avitum AG
• Labeler DUNS: 343689704
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2017-01-18
• Public Version: 7
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: a8d3c22e-ecc8-4959-8c1d-187e045e8880
• Distribution End Date: 2021-10-12

Device Description

HELP BIC EL HCL US 5000ML

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
35849	Haemodialysis concentrate	A product intended to be mixed with water to prepare a solution with an electrolyte composition similar to that of blood (i.e., a dialysate) for the exchange of solutes with blood through a semi-permeable membrane in the dialyser of a haemodialysis system. It is intended to remove metabolic waste from the blood to help maintain physiological blood electrolyte and pH levels. The product typically includes glucose and salts of the following constituents: sodium, potassium, magnesium, calcium, chloride, and anions of weak acids [e.g., bicarbonate (HCO3), acetate, citrate]. It is supplied as a solution or a dry powder. 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	04046964290152	GS1
Unit of Use	04046964041600	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Na+ concentration (mmol/l) : 140.000 MPL
Device Size Text, specify			Cl- concentration (mmol/l) : 112.700 MPL
Device Size Text, specify			Volume : 5000.000 ML
Device Size Text, specify			K+ concentration (mmol/l) : 4.000 MPL
Device Size Text, specify			Mg++ concentration (mmol/l) : 1.000 MPL
Device Size Text, specify			Glc concentration (g/l) : 1.000 GLI
Device Size Text, specify			Ca++ concentration (mmol/l) : 1.850 MPL
Device Size Text, specify			HCO3- concentration (mmol/l) : 37.000 MPL

Storage Conditions

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