Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015422213

FEI Number

3015422213

Entity Name

ASEPTIKITS, LLC

City/State/Country

North Salt Lake, UT, US

Establishment Address

101 North 700 West, North Salt Lake, UT 84054, US

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

AseptiKits, LLC (Owner Number: 10059956)

Owner / Operator Contact Address

101 North 700 West, North Salt Lake, UT 84054, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Vitrala Kit PALA 12 Kit ALAdrop Kit PALA 8 Kit PALA 14 Kit SyriKit EB 14 Custom Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2020-06-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AseptiKits, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015422213. Last updated year: 2026. Please use registration number 3015422213 when referencing this establishment in official correspondence.