PICC lines
HydroMID Maximal Barrier Kit
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Where to buy HydroMID Maximal Barrier Kit
We do not have contact details for Access Vascular, Inc. yet. Send a request and we will route it to the right person for your country.
HydroMID Maximal Barrier Kit models and sizes
From the FDA Global Unique Device Identification Database. Confirm with the manufacturer's instructions for use.
| Model / catalog no. | Size | MRI | Status |
|---|---|---|---|
| 80H04104 | — | MR Conditional | Available |
| 80004004 | — | MR Conditional | Available |
| 80004104 | — | MR Conditional | Available |
FDA clearances
- 510(k) K220772 December 2022
- 510(k) K203069 February 2021
Procedures that use picc lines
Frequently asked questions
What is HydroMID Maximal Barrier Kit used for?
A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.
Who makes HydroMID Maximal Barrier Kit?
HydroMID Maximal Barrier Kit is made by Access Vascular, Inc.. It is listed under picc lines and midline catheters in our device library.
What sizes does HydroMID Maximal Barrier Kit come in?
The FDA device database does not list sizes for HydroMID Maximal Barrier Kit. Check the instructions for use or ask a Access Vascular, Inc. representative.
Is HydroMID Maximal Barrier Kit MRI safe?
The FDA device database lists HydroMID Maximal Barrier Kit as MR Conditional. Always follow the specific MRI conditions in the labeling.
Is HydroMID Maximal Barrier Kit FDA cleared?
HydroMID Maximal Barrier Kit is covered by FDA submissions K220772, K203069.
How do I contact a Access Vascular, Inc. sales representative?
Access Vascular, Inc. has not listed representatives on LA Vascular yet. Visit the Access Vascular, Inc. company page for contact details.
Models, sizes and MRI status come from the FDA Global Unique Device Identification Database (GUDID); descriptions marked "provided by the manufacturer" are reviewed before publishing. Not an endorsement; follow the manufacturer's instructions for use.