Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013075752

FEI Number

3013075752

Entity Name

SMD MANUFACTURING LLC

City/State/Country

Salt Lake City, UT, US

Establishment Address

918 S 500 W STE A, Salt Lake City, UT 84101, US

Establishment Type(s)

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

Owner / Operator

SMD Manufacturing LLC (Owner Number: 10052202)

Owner / Operator Contact Address

918 S 500 W STE A, Salt Lake City, UT 84101, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

U-Tube SMD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2019-03-06
OFO	Airway Suction Kit	Anesthesiology	Class 1	868.6810	2024-05-08
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-11-29
NXZ	Dental Hygiene Kit	Dental	Class 1	872.6855	2024-05-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2018-03-29
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2024-01-03
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2021-08-31
KMK	Device, Intravascular Catheter Securement	General Hospital	Class 1	880.5210	2016-08-29

Official Correspondent

Stephanie Hess

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SMD Manufacturing LLC

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
K033276	Resmed, Ltd.	VPAP III ST-A	2004-06-07
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

Registration Number	Establishment Name	Location
3007477849	PATIENT SHIELD CONCEPTS LLC	Denver, CO, US
3019385708	OBP SURGICAL CORPORATION	Lawrence, MA, US
3025831202	TKR HUANAN ELECTRONICS (DONGGUAN) CO., LTD.	Dongguan City Guangdong, CN
3027150141	SWIFTSURE INNOVATIONS INC.	Pasadena Newfoundland and Labrador, CA
3015337348	Primecare Medical (Suzhou) Co.,Ltd.	Changshu Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013075752. Last updated year: 2026. Please use registration number 3013075752 when referencing this establishment in official correspondence.