AccessGUDID - DEVICE: VasoPrep Vein Preparation Kit (00860002037813)

GUDID

Device Identifier (DI) Information

Brand Name: VasoPrep Vein Preparation Kit
Version or Model: VAP-VSR-0002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VASOPREP SURGICAL, LLC

Primary DI Number: 00860002037813
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078468395 *Terms of Use

Device Description: VasoPrep Vein Preparation Kit

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:	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?
44552	Vein irrigation/distention set	A collection of devices used for the distention and irrigation of veins (e.g., saphenous) for testing and clearance prior to removal of a section for use as a coronary or peripheral bypass graft. It is also used for vein distention to facilitate ligating side branches in the vein. It typically consists of a standard syringe (e.g., 60 ml), various stainless steel devices (pin, spring, rod), and plastic rings and balls that are used during the process. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GBX	Catheter, Irrigation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131659	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
No Device Sizes

Device Record Status

Public Device Record Key: f27786af-86d1-4613-8335-89e644917d2c
Public Version Date: August 30, 2019
Public Version Number: 1
DI Record Publish Date: August 22, 2019