AccessGUDID - DEVICE: B.BRAUN (04039239085010)

GUDID

Device Identifier (DI) Information

Brand Name: B.BRAUN
Version or Model: 4552
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4552
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04039239085010
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Duosol™ Bicarb 35 Dialysate K2/Ca32x5000 mL (4552)

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":	Yes
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
KPO	DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

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
Special Storage Condition, Specify: DO NOT FREEZE
Special Storage Condition, Specify:
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Special Storage Condition, Specify: AVOID EXCESSIVE HEAT

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: K+ concentration (mEq/L) : 2.000 MEQ
Device Size Text, specify: Ca++ concentration (mEq/L) : 3.000 MEQ
Device Size Text, specify: Volume : 5000.000 ML
Device Size Text, specify: HCO3- concentration (mEq/L) : 35.000 MEQ

Device Record Status

Public Device Record Key: c20db317-83f7-4de6-a5d7-5f98beaabe14
Public Version Date: September 06, 2023
Public Version Number: 7
DI Record Publish Date: August 09, 2015

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: 04039239085003 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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