FDA.reportPublic FDA data

Infusomat®

Primary DI
04046964294570
Brand
Infusomat®
Company
B. BRAUN MEDICAL INC.
Model
363419
Catalog number
363419
Device description
Priming volume: 41mL, length: 129in, CARESITE®
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964294570PrimaryGS10
04046964294563Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964294570040469642945704046964294570
04046964294563040469642945634046964294563

GMDN Terms#

Term, Definition table
TermDefinition
Electric infusion pump administration set, single-useA collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-2862BBMUS_Service.EmailOrders@bbraun.com

Regulatory Flags#

DUNS number
002397347
Device count
24
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046961025153Prontosan®4006044006042026-08-09
04046964176982CONTIPLEX®3317063317062016-09-23
04046964176968CONTIPLEX®3317013317012016-09-23
04046964177026CONTIPLEX®3317553317552016-09-23
04046964177040CONTIPLEX®3317563317562016-09-23
04046964177569CONTIPLEX®3321273321272016-09-23
04046964177583CONTIPLEX®3321283321282016-09-23
04046955966288Design Options®5522095522092026-07-26
04046955836383Infusomat®4906554906552024-08-15
04046955836406Infusomat®4906564906562024-08-15
04046955664214B.BRAUN8713142U-998713142U-992026-07-12
04046964182631Infusomat®3620433620432016-09-23
04046964182679Infusomat®3624323624322016-09-23
04046964185922Infusomat®4900374900372016-09-23
04046964186080Infusomat®4901004901002016-09-23
04046964186103Infusomat®4901014901012016-09-23
04046964186141Infusomat®4901044901042016-09-23
04046964186165Infusomat®4901054901052016-09-23
04046964294013Infusomat®3624313624312016-09-23
04046964294617Infusomat®3634213634212016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10813153028312CodanCodan US CorporationFPA2026-07-31
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10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
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05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23