RA-0001
What are the 2 primary sources of truth when an item is being processed through RA-0001?
Label and DMR
What is the MedlineNIS inbox used for ?
Medline NIS Inbox- Utilized for updates to the ZQUAL table and NIS submissions
Who do you submit brand updates for MM03?
Item Master Data Team (IMD)
At what point in the process does Reed Tech occur?
After a record is accepted and approved in P360
Can we publish items that do not have Medline’s GTIN? Y/N
No, unless we have a contract with a private labeled company to publish items to GUDID under their GUDID account to submit
Where is the UDI team pulling reports from when an item is being processed through RA-0001?
Workfront
Who is responsible for inputting the information into the NIS sheet when an item is being processed through non-RA-0001?
Divisional QAs
What are the three minimum fields that MUST be filled out for any item in the ZQUAL table (medical device, commodities etc.?)
EPA Treated Article, EPA Registered Item and Prop 65 Product
How long does it take for an item to Publish to the FDA and what is that waiting time called?
Grace Period – 10 days
What are the 5 categories that cannot be changed in GUDID once published?
Branding, Sterility, Latex Content, Device Count, Intended use (single use or reusable)
Who is responsible for inputting the information into the NIS sheet when an item is being processed through RA-0001?
UDI Team
Where do you store the fully populated NIS sheets?
Completed Divisional List in our Files or refer to RA-00038
What are the 5 rules to identify UDI Relevant SKUs in SAP?
MMC or Co-label ,Sales Status: 9n or Blank ,Medical Device: Yes ,Class: 1,2,3, Unclassified ,GMP Exempt: No
What is Reed Tech and what is its purpose?
Third party company that helps in GUDID submissions which provide initial approval or rejection based on data fields uploaded into the system
What is the purpose of GUDID and what does it stand for?
The Global Unique Device Identification Database and it serves as a system that stores data for identification and traceability of Medical Devices. It establishes standards for the Medical Device industry, ensures public safety, quality control, setting clear guidelines for business and manufacturing.
If there is missing or inaccurate data, who do you go to?
QA and Labeler
Why do we have to refer to QAs for data?
Because we do not have access to Label and DMR
When is a unit of use DI assigned to an item in MM03?
When an item has a device count in the lowest sellable packaging quantity is more than 1. I.e., a box of 50 bandages will have a phantom DI assigned to each individual bandage.
What is the difference between Reed Tech Merge File and a Reed Tech Create File?
RT Merge File is used to update a mass of already published data. RT Create File is to create a new record in Reed Tech
What year was the FDA Final rule published and how does it affect the UDI Team?
2013, It affects us because we are out of compliance and have an immense backlog of items that need to be published.
Which source of truth trumps every other source when there is conflicting data and why?
The Label is the final word because it is what our customers see and is out in the market
How often are non-RA-0001 items sent out to Divisions and by who?
Every Tuesday and from the Medline NIS Inbox which is the UDI team
Why is the ZQUAL table so important?
It is our primary source of truth and connects to other critical systems
How many validations does Reed Tech conduct before submitting to the FDA?
Reed Tech conducts a system validation and a FDA validation before submitting to GUDID
What is the only brand in GUDID that we know is false and would need the record to be unlocked or new SKU would need to be created?
“PENDING”