AccessGUDID - DEVICE: ABVISER (00768455127993)

GUDID

Device Identifier (DI) Information

Brand Name: ABVISER
Version or Model: 420760
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 420760
Company Name: CONVATEC, PURCHASING DEPARTMENT

Primary DI Number: 00768455127993
Issuing Agency: GS1
Commercial Distribution End Date: May 20, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 809784593 *Terms of Use

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

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEN	Device, Cystometric, Hydraulic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 570ba076-c5f7-464e-a247-3e8aecbf2060
Public Version Date: May 23, 2022
Public Version Number: 3
DI Record Publish Date: September 01, 2016