FDA.reportPublic FDA data

Omnifix™

Primary DI
04046963452414
Brand
Omnifix™
Company
B. BRAUN MEDICAL INC.
Model
9161422-02
Catalog number
9161422-02
Device description
1 mL TB 25 Ga. x 5/8 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
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046963452414PackageGS116Not in Commercial Distribution
04046963452407PrimaryGS10
04046964354373Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046963452414040469634524144046963452414
04046963452407040469634524074046963452407
04046964354373040469643543734046964354373

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
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
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
04046955840878Clik-Fix®ECS-1000BECS-1000B2025-01-12
04046955840908Clik-Fix®ECS-2000BECS-2000B2024-12-08
04046961024811Blood Administration Set4700824700822026-05-10
04046964303326IV Administration Set4901734901732026-05-10
04046964727078EASYPUMP4434447-024434447-022016-09-23
04046964727139EASYPUMP4434455-024434455-022016-09-23
04046964183232Perifix®4150044150042016-09-23

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