AccessGUDID - DEVICE: BladderScan® (00879123002518)

GUDID

Brand Name: BladderScan®
Version or Model: BVI 6000 Series
Catalog Number: 0620-0225
Company Name: VERATHON INC

Primary DI Number: 00879123002518
Issuing Agency: GS1
Device Count: 1

Device Description: No description.

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:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Ultrasound system quality assurance device	An instrument used for quality assurance (QA) purposes to check the calibration and performance of systems that produce ultrasound waves used for diagnostic or therapeutic applications. This includes a variety of instruments used to measure parameters associated with beam production, beam quality, image quality and other system performance parameters.

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10879123002515	1	00879123002518		In Commercial Distribution

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

No Customer Contact currently defined