New Health Sciences Manufacturing

FDA Device Registration & Listing · Avon, MA, US · Registration 3018733946

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
3018733946
FEI Number
3018733946
Entity Name
New Health Sciences Manufacturing
City/State/Country
Avon, MA, US
Establishment Address
254 Bodwell St Ste E, Avon, MA 02322, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Hemanext Inc. (Owner Number: 10049356)
Owner / Operator Contact Address
99 Hayden Ave., Building B Suite 620, Lexington, MA 02421, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
BK251294
PMA Number
N/A

All Registered Proprietary Names

Hemanext ONE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QYC Container System For The Processing And Storage Of Red Blood Cell Components Under Reduced Oxygen Conditions Hematology Class 2 864.9115 2026-04-22

Official Correspondent

Timothy Burton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hemanext Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018733946. Last updated year: 2026. Please use registration number 3018733946 when referencing this establishment in official correspondence.
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