FDA.reportPublic FDA data

Qora Aeon Stool Management Kit

Primary DI
00860974000310
Brand
Qora Aeon Stool Management Kit
Company
Consure Medical Private Limited
Model
MG-12015-001
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860974000310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860974000310008609740003108609740003100860974000310

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
650869782
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860974000334Qora Collection BagMG-62015-0012017-11-30
00860974000341Qora Aeon Stool Management KitMG-12015-0022017-11-23
00860974000358Qora AIM Stool Management KitMG-22014-0012017-11-23
00860974000303Qora AIM Stool Management KitMG-01975-0022016-08-10
00860974000327Qora Arida Stool Management KitMG-12014-0012016-08-10

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