ClensTech Inc.dba ASEPT PAK INC.

FDA Device Registration & Listing · Malone, NY, US · Registration 3007177643

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
3007177643
FEI Number
3007177643
Entity Name
ClensTech Inc.dba ASEPT PAK INC.
City/State/Country
Malone, NY, US
Establishment Address
64 West Street, Malone, NY 12953, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Asept Pak Inc. (Owner Number: 10024698)
Owner / Operator Contact Address
64 West Street, Malone, NY 12953, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

PulmoSal (pH+) 7%, pH 7.4 Nutrifill

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2015-12-17
MRC Products, Contact Lens Care, Rigid Gas Permeable Ophthalmic Class 2 886.5918 2020-12-23
FQH Lavage, Jet General Hospital Class 2 880.5475 2011-12-29

Official Correspondent

Tracy Roth

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Asept Pak 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
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K213616 Becton, Dickinson and Company BD Surgiphor Antimicrobial Irrigation System 2022-03-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2022 Contamac Solutions, Inc. 2
Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml ampoules (360ml), UDI:00850012123002

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007177643. Last updated year: 2026. Please use registration number 3007177643 when referencing this establishment in official correspondence.
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