DEVICE: Omnican® (04046963456818)

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Device Identifier (DI) Information

Omnican®
9151141US
9151141US
B. BRAUN MEDICAL INC.
04046963456818
GS1
100
OMNICAN 100 1 ML INSULIN U-100 30GX12
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Insulin syringe/non-retractable-needle A sterile device consisting of a calibrated barrel (cylinder) with plunger, with a permanently-attached needle (usually capped for user protection), intended to be used to administer an injection of insulin to a patient subcutaneously. It is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement; the needle is not retractable. It can be used by healthcare personnel or patients, 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.
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FDA Product Code

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Product Code Product Code Name
FMF Syringe, piston
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Gauge (cannula) : 30
Outer Diameter: 0.3 Millimeter
Device Size Text, specify: Length of cannula (inch) : 1/2"
Device Size Text, specify: Length of cannula (metric) : 12.000 MM
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Device Status

Not in Commercial Distribution
September 23, 2016
June 29, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
04046963456825 24 04046963456818 2017-06-29 Not in Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: 04046964354342 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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