B.BRAUN 8713142U

GUDID 04046963716776

SpaceStation with SpaceCom

B. BRAUN MEDICAL INC.

Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile Infusion pump management unit, mobile
Primary Device ID04046963716776
NIH Device Record Keyf95bc124-05c6-45d3-bbc7-b6c9c9eff767
Commercial Distribution StatusIn Commercial Distribution
Brand NameB.BRAUN
Version Model Number8713142U
Catalog Number8713142U
Company DUNS002397347
Company NameB. BRAUN MEDICAL INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com
Phone+1(800)227-2862
EmailBBMUS_Service.EmailOrders@bbraun.com

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104046963716776 [Primary]

FDA Product Code

FRNPump, infusion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-04-09
Device Publish Date2016-09-23

On-Brand Devices [B.BRAUN]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.