Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2183771

FEI Number

2183771

Entity Name

ULTI MED, INC.

City/State/Country

De Smet, SD, US

Establishment Address

710 Fourth Street, De Smet, SD 57231, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ULTI MED, INC. (Owner Number: 2183771)

Owner / Operator Contact Address

350 Highway 7, --, Excelsior, MN 55331, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K152410

PMA Number

N/A

All Registered Proprietary Names

UltiCare Disposable Pen Needles Simpli Health Mart. PHARMACY Sunmark GOOD NEIGHBOR PHARMACY Life Brand UltiCare UltiCare Others UltiCare syringes Others UltiGuard Home Insulin Pen Needle UltiCare Simpli AND OTHERS ULTICARE DISPOSABLE NEEDLES SHINA Ulti Guard UltiCare

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-12-20
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-01-21
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2008-07-15
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2008-07-15
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-06-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2021-03-18
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2007-04-24
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-04-24
MMK	Container, Sharps	General Hospital	Class 2	880.5570	2008-01-21
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ULTI MED, 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
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
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183771. Last updated year: 2026. Please use registration number 2183771 when referencing this establishment in official correspondence.