ONETOUCH MEDICAL, LLC

FDA Device Registration & Listing · Cypress, TX, US · Registration 3042953454

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3042953454
FEI Number
3042953454
Entity Name
ONETOUCH MEDICAL, LLC
City/State/Country
Cypress, TX, US
Establishment Address
19005 Fm 529 Rd Ste 6f, Cypress, TX 77433, US
Establishment Type(s)
Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
ONETOUCH MEDICAL, LLC (Owner Number: 10094657)
Owner / Operator Contact Address
17447 Turquoise Stream Dr, Houston, TX 77095, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K190002
PMA Number
N/A

All Registered Proprietary Names

EASYTOUSE INSULIN SYRINGE EASYTOUSE U-100 INSULIN SYRINGE

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 2025-12-14
FMF Syringe, Piston General Hospital Class 2 880.5860 2025-12-14

Official Correspondent

UMUT KOC

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ONETOUCH MEDICAL, 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
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 3042953454. Last updated year: 2026. Please use registration number 3042953454 when referencing this establishment in official correspondence.
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