FDA.reportPublic FDA data

Perfusor®

Primary DI
04046964958250
Brand
Perfusor®
Company
B. BRAUN MEDICAL INC.
Model
8713040U-99
Catalog number
8713040U-99
Device description
PERFUSOR SPACE ACM-KIT, ASSET
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964958250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964958250040469649582504046964958250

GMDN Terms#

Term, Definition table
TermDefinition
Bedside syringe pumpA mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00FRAGILE MEDICAL INSTRUMENT
Special Storage Condition, Specify00Fragile, handle with care

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955672370Design Options®5606805606802026-05-24
04046955850839Omnifix®4616025V-024616025V-022026-03-08
04046955897186Design Options®5703495703492026-03-02
04045928020866Design Options®5521505521502026-02-03
04046955900534Perifix®5520475520472026-02-03
04046955900855Design Options®5555255555252026-02-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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