B.BRAUN 4552

GUDID 04039239085010

Duosol™ Bicarb 35 Di alysate K2/Ca32x5000 mL (4552)

B. BRAUN MEDICAL INC.

Haemodialysis concentrate

• Primary Device ID: 04039239085010
• NIH Device Record Key: c20db317-83f7-4de6-a5d7-5f98beaabe14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: B.BRAUN
• Version Model Number: 4552
• Catalog Number: 4552
• Company DUNS: 002397347
• Company Name: B. BRAUN MEDICAL INC.
• Device Count: 2
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0
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Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DON'T EXPOSE TO EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT
• Special Storage Condition, Specify: Between 0 and 0 *DO NOT FREEZE
• Special Storage Condition, Specify: Between 0 and 0
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *AVOID EXCESSIVE HEAT

Device Identifiers

Device Issuing Agency	Device ID
GS1	04039239085003 [Unit of Use]
GS1	04039239085010 [Primary]

FDA Product Code

• KPO: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-03
• Device Publish Date: 2015-08-09

On-Brand Devices [B.BRAUN]

• 04046964656101: Transfer Set - 26 Lines
• 04046964366383: Bloodline Extension Set (3 ft tubing)
• 04046964247385: Hemodialysis Administration Set
• 04046963330910: Duosol™ Bicarb 35 Dialysate K4/ Ca3 2x5000 mL (4555)
• 04045928000202: POLE CLAMP SP
• 04039239088295: Duosol™ Bicarb 25 Dialysate K2/ Ca0 2x5000 mL (4553)
• 04039239085010: Duosol™ Bicarb 35 Di alysate K2/Ca32x5000 mL (4552)
• 04046964350009: ALLERGAN UNIVERSAL FILL KIT
• 04046964338472: ALLERGAN 21 GA. WINGED INFUSION SET
• 04046964349928: ALLERGAN 21GA WINGED INF SET
• 04046964341298: BBRAUN MEDICAL 21G X 4.4CM WINGED INF
• 04046964338434: ALLERGAN 21GA WINGED INFUSION,SINGLE PK
• 04046964602405: IV ADMIN SET W/ 60 DROPS/ML,141 in.
• 04046963716783: SPACECOVER COMFORT - US VERSION
• 04046963716776: SpaceStation with SpaceCom
• 04046963716769: SpaceStation
• 04046955194841: CARESITE® Needleless Connector, 10" Bonded High Pressure Standard Bore Y-Type Extension Set
• 04046955194827: CARESITE® Positive Dis placement Needleless Connectors, 8" Bonded High Pressure Bifurcated Smal
• 04022495824943: BBM SWEDEN MINI SPIKE VAC TRAN
• 04046964715693: Single Shot Nerve Block Support Tray (Kit) with Ultrasound Transducer Cover and Gel (SNB000U)
• 04046964561535: GOVNB400 NON-STIMULATING CATHETER TRAY
• 04046964559624: GOVST200 SPINAL SUPPORT TRAY
• 04046964245107: EVA Gravity Mixing Container, 3-lead Vented Transfer Set, 3000 mL
• 04046964244971: EVA Gravity Mixing Container, 3-lead Vented Transfer Set, 2000 mL
• 04046964244940: EVA Gravity Mixing Container, 3-lead Vented Transfer Set, 1000 mL
• 04046964232169: EVA Gravity Mixing Container, 2-lead Vented Transfer Set, 3000 mL
• 04046964232138: EVA Gravity Mixing Container, 2-lead Vented Transfer Set, 2000 mL
• 04046964232107: EVA Gravity Mixing Container, 2-lead Vented Transfer Set, 1000 mL
• 04046964232077: EVA Gravity Mixing Container, 2-lead Vented Transfer Set, 500 mL
• 04046964177408: Nerve Block Support Tray (Kit) (NB100)
• 04046964085673: POWER SUPPLY SP US III
• 04046955623754: ST300C ANESTHESIA SUPPORT TRAY
• 04046955623747: ST200C ANESTHESIA SUPPORT TRAY
• 04046955623730: ST200DCOPM ANESTHESIA SUPPORT TRAY
• 04046964775031: VENTED SPIKE WITH AIF
• 04022495769961: Intermittent Injection Port with 19 Ga. x 1 in. Needle
• 04046963112202: Duosol™ Bicarb 32 Dialysate K2/Ca0 2x5000 mL (4554)
• 04046963563929: Duosol™ Bicarb 25 Dialysate K4/Ca0 2X5000 mL (4556)
• 04039239085089: Duosol™ Bicarb 35 Dialysate K0/Ca3 2X5000 ML (4551)
• 04046955696284: MENTOR TISSUE EXPANDER FILL KIT
• 04046955735495: NRFit® Compatible Syringe Cap
• 04046964775017: MEDIA TRANSFER SET WITH ULTRASITE VALVE
• 04046955130023: SNGL SHOT PNB SUPPORT TRAY NRFIT
• 04046955840809: FN5218 FILTER NDL 18GA X 1.5
• 04046955840847: IN2018 INTERMIT INJ PORT
• 04022495769848: Backcheck Valve with 17 Ga. x 1 in. Needle