FDA.reportPublic FDA data

hygh-tec

Primary DI
04260566430123
Brand
hygh-tec
Company
Advanced Medical Balloons GmbH
Model
V01-10025
Device description
hygh-tec drainage | 3 bags stool drainage system with three bags
Published
2023-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260566430239PackageGS120In Commercial Distribution
04260566430123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260566430239042605664302394260566430239
04260566430123042605664301234260566430123

GMDN Terms#

Term, Definition table
TermDefinition
Invasive faecal incontinence kitA collection of devices intended to be used for the conveyance and collection of 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, disposable collection bag, syringe, connectors, and ports for balloon inflation and irrigation and/or to deliver medication. The catheter is inserted into the rectum where it is retained 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1 650 843 5862info@hyghtec.com
+4972544039750quality@hyghtec.com

Regulatory Flags#

DUNS number
312633078
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260566430116hygh-tecV01-10024V01-100242023-03-06
04260566430147hygh-tecV01-10026-052023-03-06
04260566430154hygh-tecV01-10026-102023-03-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G461CEGCT40M0EndolumikEndolumik, Inc.KNT2026-08-25
00350770006840CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770007922CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770009094CORTRAK* Enteral Access SystemAvanos Medical, Inc.KNT2026-08-21
00350770009117CORTRAK* Enteral Access System - Reusable CableAvanos Medical, Inc.KNT2026-08-21
00350770007557CORFLO* Safety PEG KitAvanos Medical, Inc.KNT2026-08-14
00842071146436MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071146443MINI Balloon ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-07-17
00842071153083NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153106NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00842071153120NutraGlide Nasal Feeding TubeAPPLIED MEDICAL TECHNOLOGY, INC.KNT2026-06-10
00816340021632EL-SPIKE-MNEODEVICES INCKNT2026-06-01
00816340021649EL-SPIKE-FNEODEVICES INCKNT2026-06-01
00816340021656EL-S55-HFNEODEVICES INCKNT2026-06-01
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
08015262035662NUTRIFITPENTAFERTE ITALIA SRLKNT2025-07-03
00860007229428QoraCM TECHNOLOGIES, INC.KNT2025-03-12
G461EGCT36M0EndolumikEndolumik, Inc.KNT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.KNT2024-08-06
08015262022259VYGONVygon CorporationKNT2024-05-08
10192253007565ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007589ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007602ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007626ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007640ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007763ArgyleCardinal Health 200, LLCKNT2024-04-12
10192253007800KangarooCardinal Health 200, LLCKNT2024-04-12