AccessGUDID - DEVICE: ARTERIAL WAND (00859821006698)

GUDID

Device Identifier (DI) Information

Brand Name: ARTERIAL WAND
Version or Model: 3Fr x 5cm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 96001
Company Name: ACCESS SCIENTIFIC, LLC

Primary DI Number: 00859821006698
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079290879 *Terms of Use

Device Description: The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology

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:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40601	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	Introducer, Catheter
DQY	Catheter, Percutaneous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181563	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 21 Gauge
Catheter Gauge: 3 French
Catheter Length: 5 Centimeter

Device Record Status

Public Device Record Key: 20dd937d-639a-4b97-8d14-05129c601527
Public Version Date: November 12, 2018
Public Version Number: 1
DI Record Publish Date: October 11, 2018