AccessGUDID - DEVICE: Bard® Intra-abdominal Pressure Monitoring Device (00801741121098)

GUDID

Device Identifier (DI) Information

Brand Name: Bard® Intra-abdominal Pressure Monitoring Device
Version or Model: IAP001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IAP001
Company Name: C. R. Bard, Inc.

Primary DI Number: 00801741121098
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016898496 *Terms of Use

Device Description: Bard Intra-abdominal Pressure Monitoring Device

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47505	Intra-abdominal pressure measurement set, mechanical	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHU	Intra-abdominal pressure monitoring device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 56691321-6694-434a-ac9b-38be9d8ddb30
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 07, 2016