FDA.report

ABVISER

Primary DI
00768455127993
Brand
ABVISER
Company
CONVATEC, PURCHASING DEPARTMENT
Model
420760
Catalog number
420760
Device description
ABVISER AV IAP COM W/ARGON T'DUCER, POLE
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FENDevice, Cystometric, Hydraulic

Product Code Classifications

CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00768455128136PackageGS110In Commercial Distribution
00768455127993PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00768455128136007684551281367684551281360768455128136
00768455127993007684551279937684551279930768455127993

GMDN Terms

TermDefinition
Intra-abdominal pressure measurement set, electronicA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-422-8811cic@convatec.com

Regulatory Flags

DUNS number
809784593
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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