FDA.reportPublic FDA data

AVANTGARDE

Primary DI
15060182171891
Brand
AVANTGARDE
Company
PROSYS INTERNATIONAL LIMITED
Model
AVG100+T
Device description
Fecal Management System
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193325000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193325000Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement PouchesProsys International, Ltd.2020-03-13KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060182171894PrimaryGS10
15060182171891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060182171894050601821718945060182171894
1506018217189115060182171891

GMDN Terms#

Term, Definition table
TermDefinition
Faecal incontinence kitA collection of devices used for the conveyance and collection of liquid/semi-liquid stool (faeces) from the rectum to a collection bag for a patient who is unable to control stool discharge. It typically includes a balloon catheter, a disposable collection bag, a syringe, connectors, and ports for balloon inflation and irrigation. The catheter is inserted into the rectum where it is retained by the inflatable balloon for a prescribed length of time. The kit is appropriate for adult patients in an intensive care unit (ICU), other acute care settings, or for persons with a disability. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
221836112
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060182172112AVANTGARDEAVG2002023-10-20
05060182171894AVANTGARDEAVG100+T2023-10-20
15060182171556AVANTGARDEAVG2002023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253011210KangarooCardinal Health 200, LLCKNT2026-04-17
10192253006834Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006841Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006858Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253006865Salem SumpCardinal Health 200, LLCKNT2026-01-16
10192253011449CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011463CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011487CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011517CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011531CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011555CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011579CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011593CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
10192253011616CARDINAL HEALTHCardinal Health 200, LLCKNT2025-12-19
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
10192253011128KangarooCardinal Health 200, LLCKNT2025-05-28
10192253011159CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011173CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011197CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011227CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011258CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011272CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011296CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011630CARDINAL HEALTHCardinal Health 200, LLCKNT2025-04-03
10192253011104KangarooCardinal Health 200, LLCKNT2025-01-14
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
10192253011319KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011326KangarooCardinal Health 200, LLCKNT2024-06-13
10192253011333KangarooCardinal Health 200, LLCKNT2024-06-13