FDA.reportPublic FDA data

NA

Primary DI
04046961020790
Brand
NA
Company
B. BRAUN MEDICAL INC.
Model
339169
Catalog number
339169
Device description
STERIFIX FIL NEEDLE 5MIC,19GX1.5IN NRFIT
Published
2025-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046961020790PrimaryGS10
04046964943232Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046961020790040469610207904046961020790
04046964943232040469649432324046964943232

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer needle, filteringA slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. 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
100
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964813993Design Options®5301605301602016-09-23
04022495101211Stimuplex®489426048942602016-09-23
04046955966295Design Options®5522105522102026-10-18
04022495101167Stimuplex®489425148942512016-09-23
04022495101266Stimuplex®489427848942782016-09-23
04022495101310Stimuplex®489450248945022016-09-23
04022495166579Stimuplex®489436748943672016-09-23
04022495187826Stimuplex®489453948945392016-09-23
04046955665075Extension Set4906304906302021-02-08
04046964991257Extension Set4904864904862017-04-03
04046955270347IV Administration Set4905504905502019-02-22
04046955287475IV Administration Set4905744905742018-10-05
04046955203307IV Administration Set4905294905292018-06-15
04046964296734Extension Set4565224565222016-09-23
04046955874330INTROCAN SAFETY®4251610-024251610-022026-10-11
04046955765164IV Administration Set4906404906402026-09-27
04046955114559IV Administration Set4905014905012026-09-19
04046955862658Design Options®5522045522042026-08-17
04046955966233Design Options®5302095302092026-08-17
04046955966370Design Options®5703615703612026-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09347144017596Metier MedicalMETIER MEDICAL LTDGAA2026-10-19
00860015723901NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723918NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723925NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
00860015723932NerveAction SolutionsNerveAction Solutions Inc.GAA2026-10-15
10198956491298CARDINAL HEALTHCardinal Health 200, LLCGAA2026-10-12
00817295020138InradInradGAA2026-10-09
00817295020145InradInradGAA2026-10-09
00817295020183InradInradGAA2026-10-09
00817295020190InradInradGAA2026-10-09
00817295020206InradInradGAA2026-10-09
00817295020213InradInradGAA2026-10-09
00817295020220InradInradGAA2026-10-09
00817295020237InradInradGAA2026-10-09
00817295020244InradInradGAA2026-10-09
00817295020251InradInradGAA2026-10-09
00817295020268InradInradGAA2026-10-09
00817295020275InradInradGAA2026-10-09
00817295020282InradInradGAA2026-10-09
00817295020299InradInradGAA2026-10-09
00817295020305InradInradGAA2026-10-09
00817295020312InradInradGAA2026-10-09
00817295020329InradInradGAA2026-10-09
00817295020336InradInradGAA2026-10-09
00817295020343InradInradGAA2026-10-09
00817295020350InradInradGAA2026-10-09
00817295020367InradInradGAA2026-10-09
00817295020374InradInradGAA2026-10-09
00817295020381InradInradGAA2026-10-09
00817295020398InradInradGAA2026-10-09