Frequently asked questions

How do I use BluList to track medical devices?


Download our App on Android or iPhone. Login. Scan any medical device. All your scans will be recorded and accessible to you on BluList.io




Can I see other users tracking activity?


You need to add a user to your team to see their tracking activity. If you register as a manufacturer you can see limited data on all scans of your products to help you comply to FDA recall regulations.




How do I register as a manufacturer?


Login here and create your team. Choose " Manufacturer" during the team set up dialogue and then find your company on the list of FDA recognized manufacturers. The system will email an authorization request to the email address your company has on file with the FDA.




How do I add other users?


Each team can invite new users and assign them different access priviledges based on user type.




How do I record shipping details for FDA compliant record keeping?


When you scan a devcie with your smartphone App simply pick "Ship" and then choose from your address book.




How do I mark an item as used?


Scan the item with your smartphone App and set its status to destroyed.




I need to create a new storage location?


For Iphone - scan a device and select "add new location" or go to settings "My Storage Locations" press "+" and specify the location name. For Android - scan a device and select "add new location"




How do I sync to Dropbox?


Login. Click on your avatar. Under your account settings click on the dropbox icon and follow the prompts. - Dropbox requires us to sync in batches. There may be a slight delay in pushing the PDF copy of your persistent ledger after a scan. If you have a large number of records before turning on dropbox it may take a few minutes to sync them all. - To be FDA compliant with your electronic records you may need to sign up for a business dropbox acocunt




How do I sync to GDrive?


Login. Click on your avatar. Under your account settings click on the google drive icon and follow the prompts. - Google drive requires us to sync in batches. There may be a slight delay in pushing the PDF copy of your persistent ledger after a scan. If you have a large number of records before turning on Google Drive it may take a few minutes to sync them all.




What is a UDI?


A UDI is a mandatory identifying code that is unique to every Type II medical device sold in the United State as of September 24th 2016.




Where is the UDI on my device?


The UDI must be clearly shown in machine and human readable format on the label or directly on the medical device.




Does the FDA issue UDI's


No. The FDA keeps a record of the different types of device in its GUDID database. They have authorized three companies to issue UDI's.




Does BluList issue UDI's?


No. BluList allows you and your team to keep a record of the devices you have scanned, check the data stored by the FDA on those devices. If you are a manufacturer you can also add relevant information to each product you sell.




Who Issues UDI's?


The FDA have accredited three issuing agencies for UDI’s. Manufacturers have to use these to create UDI’s for their medical devices.

  • GS1

  • Health Industry Business Communications Council (HIBCC),

  • International Council for Commonality in Blood Banking Automation (ICCBBA)




What do your Apps do?


The App does two things:

1. It allows you to scan a UDI with your smartphone and directly check the details held by the FDA - no more typing

2. It allows users to add data about where a particular device is or is going

This extra data can then be shared between interested users on the system.




What does BluList do?


Using our smartphone apps you can keep a record of what you have scanned, where you stored it, if you have used it or if you have shipped it (and the shipping address - in case you need to report it to the FDA)

Using our webapp you can

- Share your scan history with a team.

- Manage inventory at medical centres.

- Catalogue and search your network so you can share resources.

- Find the last person to use a Medical Device so you can ask them where they left it!

- Communicate with the manufacturer




I noticed you track location. Why?


We track location to be able to help you manage your stock and keep track of things by leveraging Authentag's (our parent company's) unique identification and tracking system.




What is the required format of a UDI?


UDI’s must be machine and human readable so a barcode or barcodes and a string of characters.

They consist of two parts

DI or Device identifier - this identifies the manufacturer and the type of device you are buying
PI or Production Identifiers - this can be used to identify the exact unit and can give other useful information like expiry date or batch number




I'm a manufacturer - what are my obligations?


Manufacturers have been legally required to put a full UDI on every class II medical device from September 2016.

They are also required to register the DI part of the code with the FDA by entering it into the FDA’s GUDID database along with some other useful information about the device.

They can do this themselves or empower the issuing agency to do it for them.

They must also keep goo and accurate records of where they ship each individual device, in orde to favilitate recalls.




I'm a sole operator - do I need a team?


You can be a team of one. If you only need to search items listed with us, this feature will still be available to you when your team expires.




How many teams can I join?


You can join as many teams as you need. If you manage a large organization, consider creating one team for all your employees and then smaller teams for each group.




Can I delete a team?


Any team can be deleted if you have not started payments. If you have paid, we'll maintain the team even if you cease payment. You'll be able to see all the historic data but it will not be updated and so may be inaccurate.




My phone has a lot of scans in the history - anyway to hide them?


Yes. You can remove scans from your phone. 1. Log in to BluList.io on your phone it will sync all the scans to your persistent electronic ledger and share them with any team you are a member of. 2. Log out of BluList.io on your phone and it will clear the phones history of all previous scans. They are still stored on BluList.io 3. Log back in to BluLilst.io on your phone to keep both your webapp and your phone app in sync!




Why doesn't my phone history match my webapp history?


If you have ever logged in and then out of your account on your phone you will have cleared the cache of scans. Don't worry, you can view your entire history on the webapp.




Why can't I see my teams scans on my phone


To see your teams scans on your phone you can log in to the secure webapp at www.blulist.io... As the website is mobile friendly we chose to keep your App as light as possible to make scanning as fast as possible.




Can I use my Apps when I am offline?


Currently if you don't have a data connection then you cannot operate the phone apps. Our phone apps are linked directly to the FDA to make sure you have up to date information on the device you are scanning. Also there are over 1.4 million devices listed, we cannot store them all on your phone.





MEDICAL DEVICE TRACKER

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