Bard Intra-abdominal Pressure Monitoring Device

Bard Intra
Bard® Intra-abdominal Pressure Monitoring Device - IAP001

A collection of devices designed to measure intra-abdominal pressure (IAP) through the bladder. It typically includes a tube with graduated markings in mm Hg (manometer tube), clamps, a filter, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), and IAP is measured by the manometer tube based on urine level in the tube. It is typically used to measure IAP in patients at risk of intra-abdominal hypertension (IAH) such as following abdominal surgery, abdominal trauma, ventilated patients with organ dysfunction, and patients suspected of abdominal compartment syndrome (ACS). This is a single-use device.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PHU

Device Name: Intra-Abdominal Pressure Monitoring Device

Device Class: U

Physical State: Urological catheter, pressure sensing device.

Definition: Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Monitoring abdominal intracompartmental pressure with a urological catheter

Life Sustain Support Flag: N

Unclassified Reason: 1

Implant Flag: Y

Target Area: Urological

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 10801741121095

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741121098

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741121098

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A