AccessGUDID - DEVICE: NeoMagic (B339194316250)

GUDID

Device Identifier (DI) Information

Brand Name: NeoMagic
Version or Model: 1943-1625
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1943-1625
Company Name: NEO MEDICAL INC.

Primary DI Number: B339194316250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015510540 *Terms of Use

Device Description: 1.9Fr x 25cm, Single Lumen PICC with Stylet

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	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
Peripherally-inserted central venous catheter	A sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Peripherally-inserted central venous catheter

A sterile, thin, flexible tube intended to be introduced into a peripheral vein and advanced to a central vein for short- to long-term intravascular access to administer medications (antibiotics), chemotherapeutic agents, nutrients, parenteral solutions, pain management fluids, and sometimes for blood sampling, monitoring of blood pressure and temperature, and for power injection of contrast media; it is not primarily intended for extracorporeal blood therapies such as haemodialysis. Also known as a peripherally inserted central catheter (PICC), it typically includes dedicated accessories to facilitate catheter introduction/function (e.g., Luer hubs, stylet). This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
LJS	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K953300	000

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

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Storage and Handling
Special Storage Condition, Specify: Keep Dry
Special Storage Condition, Specify: Keep Away From Sunlight

Clinically Relevant Size

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Size Type Text
Length: 25 Centimeter
Catheter Gauge: 1.9 French

Device Record Status

Public Device Record Key: dc556c36-33f0-4639-84bf-0530f629c36e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016