Z Vent K233486 — Device overview

Device Icon

Proprietary Name

Z Vent

Class 2 (Moderate Risk)

Device Name

Ventilator, Continuous, Facility Use

Primary Manufacturer

ZOLL MEDICAL CORPORATION

Specialty

Anesthesiology

Device Information

The K Number is a unique identifier assigned by the FDA for tracking medical devices. The Regulation Number references the specific FDA regulation that governs the device, confirming its registration and compliance with FDA standards for easy regulatory verification.

Source
K Number
K233486
Unique FDA identifier
Regulation Number
868.5895
FDA regulation reference

Manufacturer Information

The Manufacturer Information section includes details about the primary manufacturer of the device, including their name and location. If applicable, it also lists the US Agent responsible for representing the manufacturer in the United States. The agent’s contact information, such as email and phone number, is provided for further communication. Additionally, the Registration Addresses section shows where the manufacturer is located worldwide and includes information about their registration status and validity, such as the Expiry Year of their registration and the establishment type (e.g., manufacturing medical devices).

Source
Primary Manufacturer
ZOLL MEDICAL CORPORATION

Registration Addresses

3 registered establishments worldwide

Registration Name
ZOLL MEDICAL CORPORATION
Expiry year
2026
Registration Number
1220908
Address
269 MILL ROAD
CHELMSFORD, MA01824
Establishment Types
Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device
Registration Name
ZOLL International Holding B.V.
Expiry year
2026
Registration Number
3029871637
Address
Einsteinweg 8A
Elst Gelderland6662 PW
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Registration Name
ZOLL MEDICAL CORPORATION
Expiry year
2026
Registration Number
3038259592
Address
38 Upton Dr
Wilmington, MA01887
Establishment Types
Repack or Relabel Medical Device

Owner/Operator Information

The Owner/Operator Information section provides details about the company or entity responsible for the device. It typically includes the company name of the device's owner or operator, as well as the business address, which is the primary location where the business operates or is registered. This information helps identify the entity managing or manufacturing the device and provides transparency regarding the responsible party for regulatory purposes.

Source
Company Name
ZOLL Medical Corporation
Device owner/operator
Business Address
269 MILL ROAD Chelmsford, MA 01824
Primary business location