Bard Intra
Bard® Intra-abdominal Pressure Monitoring Device - IAP001
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice 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