Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013221738

FEI Number

3013221738

Entity Name

AIVITA BIOMEDICAL, INC.

City/State/Country

Irvine, CA, US

Establishment Address

18301 Von Karman Ave, Suite 130, Irvine, CA 92612, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

AIVITA Biomedical, Inc. (Owner Number: 10089030)

Owner / Operator Contact Address

18301 Von Karman Ave, Suite 130, Irvine, CA 92612, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MyOwnVaccine Clean Super Vaccine MyOwnVaccine Clean Super Vaccine Clean Super Vaccine MyOwnVaccine MyOwnVaccine Clean Super Vaccine MyOwnVaccine Clean Super Vaccine Clean Super Vaccine MyOwnVaccine

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-11-09
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2023-11-09
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2023-11-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2023-11-09
KIT	Media And Components, Synthetic Cell And Tissue Culture	Hematology	Class 1	864.2220	2023-11-09
JCF	Lymphocyte Separation Medium	Hematology	Class 1	864.8500	2023-11-09

Official Correspondent

Rockelle Robles

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AIVITA Biomedical, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K832690	Sigma Chemical Co.	MINIMUM ESSENTIAL MED. EAGLE M0268	1983-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620
Z-0018-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Z-0023-2011	Becton Dickinson & Company	1	BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes

Similar Registrations

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3005748921	ISCON SURGICALS, LTD.	JODHPUR Rajasthan, IN
9616662	MERIT MEDICAL IRELAND, LTD	Galway, IE
2029275	Sterigenics U.S., LLC	Corona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013221738. Last updated year: 2026. Please use registration number 3013221738 when referencing this establishment in official correspondence.