FDA UDI / GUDID Registration Form
Submit your Unique Device Identifier (UDI) information for registration in the FDA’s Global Unique Device Identification Database (GUDID). LMG will prepare and submit your GUDID data on your behalf.
Labeler / Company Information
The labeler is the person or company that places the UDI on the device label. In most cases this is the manufacturer.
Contact Person
Issuing Agency
Select the FDA-accredited issuing agency that issued your UDI. The three FDA-accredited agencies are GS1, HIBCC, and ICCBBA.
Device Information
Enter details for each medical device requiring UDI/GUDID submission. Device 1 is required. Click "Add Another Device" to add more.
Additional Information
Agreement
We appreciate your decision to select Liberty Management Group Ltd. ("LMG") to prepare and submit your Unique Device Identifier (UDI) information to the FDA's Global Unique Device Identification Database (GUDID) as required under 21 CFR Part 830. This Agreement describes the scope of our relationship with your company. By submitting the requested information to LMG, your company agrees to be bound by the terms and conditions listed in this document.
1. Services Provided
Our services will be limited to preparing and submitting device identification information to GUDID on your behalf. The services include preparation of GUDID data records, submission via the GUDID web interface or HL7 SPL XML via the FDA Electronic Submissions Gateway (ESG), and coordination with the relevant FDA-accredited issuing agency where required. You understand and agree that the information your company provides to LMG will be used for the purpose of completing a public submission to the GUDID, which is publicly accessible.
2. Client Information
You agree and warrant that all information your company provides to LMG, including but not limited to device identifiers, brand names, device descriptions, device class, issuing agency information, and DUNS numbers (collectively, "Client Information"), is correct and truthful to the best of your knowledge. You understand and acknowledge that LMG will rely upon the Client Information your company provides. You further agree and warrant that you will promptly inform LMG of any changes in the Client Information that require updating in the GUDID.
3. Termination Notices
Either party may terminate the relationship at any time for any reason by providing five (5) days' prior written notice to the other party. In the event of termination of this Agreement by either party, LMG shall not be liable to your company for any reimbursement or damages on account of the loss of prospective or actual sales or profits of your company. In no event shall LMG's liability exceed the amount of the fees paid by your company to LMG in any given calendar year.
4. Limitations
LMG shall not be liable for any delay in performing its obligations under this Agreement if such delay is caused by circumstances beyond LMG's reasonable control.
5. Governing Law and Venue
This Agreement and the interpretation of its terms shall be governed and construed in accordance with the laws of the State of Illinois, U.S.A., without regard to its conflicts of laws rules. The parties consent to the sole and exclusive jurisdiction and venue of the Illinois courts in Will County, Illinois, U.S.A.
Submitter Information
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