AccessGUDID - DEVICE: Vaxcel (M001459910)

GUDID

Device Identifier (DI) Information

Brand Name: Vaxcel
Version or Model: 45991
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NAVILYST MEDICAL, INC.

Primary DI Number: M001459910
Issuing Agency: HIBCC
Commercial Distribution End Date: October 18, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 809699023 *Terms of Use

Device Description: Vaxcel Mini Stick Kit with Peelable Introducer Sheath Set, 6F x 10cm Dilator, NiTi Guidewire, and Radiopaque Tip

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":	No
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRE	DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974640	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
Catheter Gauge: 6 French
Length: 10 Centimeter
Lumen/Inner Diameter: 0.5 Millimeter
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: 63be65ee-0246-4f4e-937c-7e46bb2d83f1
Public Version Date: October 21, 2024
Public Version Number: 6
DI Record Publish Date: September 15, 2015