AccessGUDID - DEVICE: Ster-ASSIST ™ (04046964712593)

GUDID

Device Identifier (DI) Information

Brand Name: Ster-ASSIST ™
Version or Model: 375500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 375500
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964712593
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Introcan Safety® 20 Ga . x 1.75 in., Straight, FEP and CARESITE® Smallbore Extension Set with bonded CARESITE Luer Access Device, Spin-Lock® connector and removable slide clamp, 8 in. (20cm). For use with power injector

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):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	Yes
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
Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Peripheral vascular catheter

A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
OWL	Peripheral catheter insertion kit

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Gauge (cannula) : 20

Device Record Status

Public Device Record Key: 74f0bb1e-dbb7-47aa-829c-63b012ca5463
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016