FDA.reportPublic FDA data

Perfusor®

Primary DI
04046963716745
Brand
Perfusor®
Company
B. BRAUN MEDICAL INC.
Model
8713030U
Catalog number
8713030U
Device description
Perfusor® Space® Infusion Pump System
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRNPump, infusion
LZHPump, infusion, enteral
MEAPump, infusion, pca

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2
LZHPump, Infusion, EnteralGeneral Hospital2
MEAPump, Infusion, PcaGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963716745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963716745040469637167454046963716745

GMDN Terms#

Term, Definition table
TermDefinition
Syringe pumpA mains electricity (AC-powered) 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 that allow the device to operate 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
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 Temperature-20 Degrees Celsius55 Degrees Celsius

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
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964315954Design Options®5554845554842016-09-23
04046964989742Design Options®5521175521172016-10-24
04046955582969Perfusor®8713330-998713330-992026-06-07
04046955862634Design Options®5522035522032026-06-01
04046955966264Design Options®5522075522072026-06-01
04046964177347Perifix®3320873320872016-09-23
04046964178900Perifix®3322643322642016-09-23
04046955672370Design Options®5606805606802026-05-24
04046955900268Design Options®5517695517692026-05-14
04046964308024Design Options®5517695517692016-09-23
04045928020392Design Options®5521235521232026-05-11
04045928020699Design Options®5521795521792026-05-11
04046955803125Clik-Fix®LLS-1021BLLS-1021B2023-01-06
04046955803163Clik-Fix®LLS-1024BLLS-1024B2023-01-06
04046955803194Clik-Fix®NPS-1006BNPS-1006B2022-12-22
04046955803231Clik-Fix®LLSK-1024BLLSK-1024B2023-01-06
04046955803255Clik-Fix®PCS-1011BPCS-1011B2022-12-22
04046955803286Clik-Fix®WCS-1000BWCS-1000B2023-03-13
04046955803316Clik-Fix®WCS-1003BWCS-1003B2023-03-06
04046955803347Clik-Fix®WCS-1006BWCS-1006B2023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10885380193071KangarooCardinal Health 200, LLCLZH2026-03-16
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
10192253068900KangarooCardinal Health 200, LLCLZH2025-09-30
10192253068917KangarooCardinal Health 200, LLCLZH2025-09-30
10192253011135KangarooCardinal Health 200, LLCLZH2025-05-28
10192253008456KangarooCardinal Health 200, LLCLZH2025-05-19
10192253009682KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009859KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009965KangarooCardinal Health 200, LLCLZH2025-05-02
10192253008418KangarooCardinal Health 200, LLCLZH2025-04-29
10192253008432KangarooCardinal Health 200, LLCLZH2025-04-29
10192253008159KangarooCardinal Health 200, LLCLZH2024-12-16
10192253023107KangarooCardinal Health 200, LLCLZH2024-12-16
10192253008371KangarooCardinal Health 200, LLCLZH2024-11-22
10192253008395KangarooCardinal Health 200, LLCLZH2024-11-22
10192253065763KangarooCardinal Health 200, LLCLZH2024-11-22
10192253008425KangarooCardinal Health 200, LLCLZH2024-10-23
10192253009613KangarooCardinal Health 200, LLCLZH2024-09-30
10192253009637KangarooCardinal Health 200, LLCLZH2024-09-30
10192253009620KangarooCardinal Health 200, LLCLZH2024-09-25
10192253009651KangarooCardinal Health 200, LLCLZH2024-09-24
10192253009989KangarooCardinal Health 200, LLCLZH2024-09-23
10192253007183KangarooCardinal Health 200, LLCLZH2024-09-03
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10192253011074KangarooCardinal Health 200, LLCLZH2023-10-24
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
50885380184152KangarooCardinal Health 200, LLCLZH2023-08-29
10885380177101KangarooCardinal Health 200, LLCLZH2023-08-04
10885380177118KangarooCardinal Health 200, LLCLZH2023-08-04