Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011097023

FEI Number

3011097023

Entity Name

CRYOPAK

City/State/Country

Edison, NJ, US

Establishment Address

551 Raritan Center Parkway, Edison, NJ 08837, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Cryopak (Owner Number: 10090190)

Owner / Operator Contact Address

11000 Parkway Boulevard, Montreal, CA-QC H1J 1R6, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot/Cold Therapeutic Bead Wrap Hot/Cold Therapeutic Bead Pack Reusable Ice Mat Ice Bandana Neowrap Ouchies Icy-Cools Dermacube Hot/Cold Reuseable Mat Reusable Ice Cubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2024-02-26

Official Correspondent

Mohamadou BA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cryopak

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 3011097023. Last updated year: 2026. Please use registration number 3011097023 when referencing this establishment in official correspondence.