FDA.reportPublic FDA data

Omnifix™

Primary DI
04046963452582
Brand
Omnifix™
Company
B. BRAUN MEDICAL INC.
Model
9161732VUS
Catalog number
9161732VUS
Device description
1 mL Insulin 27 Ga. x -1/2 in. Detachable Needle
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
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
04046963452582PackageGS116Not in Commercial Distribution
04046963435592PrimaryGS10
04046964354403Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963452582040469634525824046963452582
04046963435592040469634355924046963435592
04046964354403040469643544034046964354403

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, basicA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume1Milliliter

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
100
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
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
00810126506757Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
00810126506764Comfortox3D DENTAL DESIGNS AND DEVELOPMENT, LLCFMF2026-03-24
18699207302025Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207305033Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207310037Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207311003Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207320029Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
18699207350026Set InjectSET MEDIKAL SANAYI VE TICARET ANONIM SIRKETIFMF2026-03-17
04046955850839Omnifix®B. BRAUN MEDICAL INC.FMF2026-03-08
18800109007035DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007073DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
18800109007127DMject Insulin SyringeShinchang Medical Co., Ltd.FMF2026-03-03
00849296013345WelmedWELMED INC.FMF2026-02-15
00849296013352WelmedWELMED INC.FMF2026-02-15
00849296013369WelmedWELMED INC.FMF2026-02-15
00849296013376WelmedWELMED INC.FMF2026-02-15
00849296013383WelmedWELMED INC.FMF2026-02-15
00849296013390WelmedWELMED INC.FMF2026-02-15
00849296013406WelmedWELMED INC.FMF2026-02-15
00849296013413WelmedWELMED INC.FMF2026-02-15
00849296013420WelmedWELMED INC.FMF2026-02-15
00849296013437WelmedWELMED INC.FMF2026-02-15
00849296013444WelmedWELMED INC.FMF2026-02-15
00849296013451WelmedWELMED INC.FMF2026-02-15
00849296013468WelmedWELMED INC.FMF2026-02-15
00849296013475WelmedWELMED INC.FMF2026-02-15
00849296013482WelmedWELMED INC.FMF2026-02-15
00849296013499WelmedWELMED INC.FMF2026-02-15
00849296013505WelmedWELMED INC.FMF2026-02-15
20850083784007Comfort EZS.D.I. USA, INC.FMF2026-02-13