FDA.reportPublic FDA data

Omnifix™

Primary DI
04046963432454
Brand
Omnifix™
Company
B. BRAUN MEDICAL INC.
Model
4610518-02
Catalog number
4610518-02
Device description
5 mL LS Syringe
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963432461PackageGS120Not in Commercial Distribution
04046963432454PrimaryGS10
04046964332326Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963432461040469634324614046963432461
04046963432454040469634324544046963432454
04046964332326040469643323264046964332326

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Contacts#

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

Regulatory Flags#

DUNS number
002397347
Device count
100
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
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
04046964294570Infusomat®3634193634192016-09-23
04046964294617Infusomat®3634213634212016-09-23
04046964294679Infusomat®3634303634302016-09-23
04046964186127Infusomat®4901024901022016-09-23
04046964294556Infusomat®3634103634102016-09-23
04046955850822Omnifix®4616025V-024616025V-022026-03-08
04046963452131Omnifix™4616308F-024616308F-022016-09-23
04046964291647CONTIPLEX®3316763316762016-09-23
04046964291807CONTIPLEX®3321293321292016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01