ABVISER

Basic Information

• Brand Name: ABVISER
• Primary DI: 00768455127993
• Version / Model: 420760
• Catalog Number: 420760
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Labeler DUNS: 809784593
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: 570ba076-c5f7-464e-a247-3e8aecbf2060
• Distribution End Date: 2022-05-20

Device Description

ABVISER AV IAP COM W/ARGON T'DUCER, POLE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FEN	Device, Cystometric, Hydraulic	Gastroenterology, Urology	876.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60450	Intra-abdominal pressure measurement set, electronic	A collection of sterile devices intended to electronically measure intra-abdominal pressure (IAP) through the bladder. It typically includes an electronic pressure transducer, syringe, tubing, connectors, and a urine collection bag. The assembled device is connected to an indwelling urethral catheter (Foley), saline is infused into the bladder and IAP is measured by the transducer and displayed on, and powered by, a wire-connected monitor. It is typically used for patients at risk of intra-abdominal hypertension (IAH) e.g., following abdominal surgery/trauma. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00768455127993	GS1
Package	00768455128136	GS1		10	Not in Commercial Distribution	2022-05-20

Customer Contacts

• Phone: [phone]
• Email: [email protected]