AccessGUDID - DEVICE: VASOBand (00866691000312)

GUDID

Device Identifier (DI) Information

Brand Name: VASOBand
Version or Model: VB-2600-AR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VB-2600-AR
Company Name: VASOINNOVATIONS INC.

Primary DI Number: 00866691000312
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071926350 *Terms of Use

Device Description: The VASOBandTM is a compression device to assist hemostasis of the radial artery after a transradial procedure.

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?
58704	Radial artery compression device	A device intended to provide compression for haemostasis to the puncture site on a patient having undergone radial artery catheterization, and can be used as an alternative to direct hand pressure. It typically consists of one or more pad/strap(s), which may also have a compression/decompression knob and a time indicator; it may be applied so that it does not compress the ulna artery or block venous return. It is typically used following coronary angiography/ventriculography or percutaneous transluminal coronary angioplasty (PTCA). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190318	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
Special Storage Condition, Specify: Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
Storage Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 4 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Circumference: 26 Centimeter

Device Record Status

Public Device Record Key: 68e59db4-7f28-4a0e-8b7b-9bdc97da6e70
Public Version Date: February 03, 2023
Public Version Number: 2
DI Record Publish Date: January 05, 2021