FDA.report

SPACE

Primary DI
04046963418373
Brand
SPACE
Company
B. BRAUN MEDICAL INC.
Model
8713152
Catalog number
8713152
Device description
SpaceStation MRI
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FRNPump, infusion

Product Code Classifications

CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046963418373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046963418373040469634183734046963418373

GMDN Terms

TermDefinition
Infusion pump management unit, mobileA mains electricity (AC-powered) mobile unit designed for the bedside organization, management, monitoring and electrical supply of many infusion pumps that are being used simultaneously to supply one patient. This device will be found in the intensive care unit (ICU) and helps achieve a high degree of organization of, e.g., the different infusion pumps, syringe pumps, the infusion sets and lines and the medication being infused.

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Humidity30 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags

DUNS number
002397347
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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04046955901197Combined Spinal & Epidural5301535301532026-02-03
04045928020200Design Options®5301855301852020-04-24
04046955966165Design Options®5703605703602026-01-25
04046955086832Extension Set4904964904962017-10-28
04046964296710Extension Set4565214565212016-09-23
04046964525728Extension Set4903164903162016-09-23
04046964296697Extension Set4565204565202016-09-23
04046964183218Perifix®4150004150002016-09-23
04046964941054PERIFIX™3391603391602016-10-24
04046964332333VENA TECH6107716107712017-01-18
04046955672028Design Options®5606765606762025-12-22
04046955745753Introcan Safety ® 24242001-024242001-022025-12-19
04046955745838Introcan Safety ® 24242003-024242003-022025-12-19
04046955745913Introcan Safety ® 24242005-024242005-022025-12-19
04046955745999Introcan Safety ® 24242007-024242007-022025-12-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885403211423Alaris™ Pump Module, Model 8100CAREFUSION 303, INC.FRN2025-12-19
10885403423208Alaris™ Syringe Module, Model 8110CAREFUSION 303, INC.FRN2025-12-19
00816989021468HK Klein Infiltration Pump+HK SURGICAL INC.FRN2025-09-29
50197886011239Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013172Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013189Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
50197886013196Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-08-25
00850017421202RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421219RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421226RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421233RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421240RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421264RemunityPROUnited Therapeutics CorporationFRN2025-08-07
00850017421271RemunityPROUnited Therapeutics CorporationFRN2025-08-07
20197886008214Novum IQBAXTER HEALTHCARE CORPORATIONFRN2025-07-07
10885403519291BD AlarisCAREFUSION 303, INC.FRN2025-06-25
M335400011ICU Medical, INC.ICU MEDICAL, INC.FRN2025-04-28
M335400031ICU Medical, INC.ICU MEDICAL, INC.FRN2025-04-28
B510IP200ADVANCED INFUSION PUMPADVANCED INSTRUMENTATIONS, INC.FRN2025-02-04
00811505030467Ivenix Infusion SystemFresenius Kabi AGFRN2024-12-06
05713495001043VYAFUSER™Phillips-Medisize A/SFRN2024-11-13
27290109155306Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
00816989021437HK Klein TDD PumpHK SURGICAL INC.FRN2024-08-29
10885403519284AlarisCAREFUSION 303, INC.FRN2024-05-24
40616258024415MEDRAD® Intego Patient Administration SetBayer Medical Care Inc.FRN2024-05-06
40616258024835MEDRAD® Intego Sterile DisposablesBayer Medical Care Inc.FRN2024-05-06
00862492000353Eitan MedicalOPTUMHEALTH CARE SOLUTIONS, INC.FRN2024-04-24
04987488102241PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12
04987488102258PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12
04987488102265PORT ACCESS INFUSION SETSB-KAWASUMI LABORATORIES, INC.FRN2024-04-12