AccessGUDID - DEVICE: Omnican® (04046963456818)

GUDID

Device Identifier (DI) Information

Brand Name: Omnican®
Version or Model: 9151141US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9151141US
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046963456818
Issuing Agency: GS1
Commercial Distribution End Date: October 20, 2017
Device Count: 100
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: OMNICAN 100 1 ML INSULIN U-100 30GX12

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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/needle, basic	A 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.

GMDN Preferred Term Name

GMDN Definition

Insulin syringe/needle, basic

A 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.

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 8c03db81-aed7-4e67-8f93-0b2f02d5c5a9
Public Version Date: June 12, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016