AccessGUDID - DEVICE: B.BRAUN (04046964290152)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 4109
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4109
Company Name: B.Braun Avitum AG

Primary DI Number: 04046964290152
Issuing Agency: GS1
Commercial Distribution End Date: October 12, 2021
Device Count: 2
Labeler D-U-N-S® Number*: 343689704 *Terms of Use

Device Description: HELP BIC EL HCL US 5000ML

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMY	LIPOPROTEIN, LOW DENSITY, REMOVAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type 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

Device Record Status

Public Device Record Key: a8d3c22e-ecc8-4959-8c1d-187e045e8880
Public Version Date: May 08, 2023
Public Version Number: 7
DI Record Publish Date: January 18, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 04046964041600 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)848-2066
Email: rtd.us@bbraun.com

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