ESTEEM

Primary DI
10768455204639
Brand
ESTEEM
Company
CONVATEC, PURCHASING DEPARTMENT
Model
423714
Device description
N/A
Published
2024-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXGBAG, URINE COLLECTING, URETEROSTOMY
EXHBAG, URINARY, ILEOSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1
EXHBag, Urinary, IleostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455204639PackageGS16In Commercial Distribution
00768455204632PrimaryGS10
00768455221974Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845520463910768455204639
00768455204632007684552046327684552046320768455204632
00768455221974007684552219747684552219740768455221974

GMDN Terms#

Term, Definition table
TermDefinition
One-piece urostomy bag, open-endedA one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18004228811cic12@convatec.com

Regulatory Flags#

DUNS number
809784593
Device count
10
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455201303AVELLE4466504466502023-02-22
00768455108268STOMAHESIVE0255102022-09-28
00768455101399ACTIVELIFE0209222018-11-09
00768455101405ACTIVELIFE0227502018-11-09
00768455101412ACTIVELIFE0227512018-11-09
00768455101429ACTIVELIFE0227522018-11-09
00768455101436ACTIVELIFE0227532018-11-09
00768455101443ACTIVELIFE227542018-11-09
00768455101450ACTIVELIFE0227552018-11-09
00768455101467ACTIVELIFE0227562018-11-09
00768455101474ACTIVELIFE0227572018-11-09
00768455101481ACTIVELIFE0227582018-11-09
00768455101498ACTIVELIFE0227592018-11-09
00768455101504ACTIVELIFE0227602018-11-09
00768455101511ACTIVELIFE0227612018-11-09
00768455101528ACTIVELIFE0227622018-11-16
00768455101535ACTIVELIFE0227632018-11-16
00768455101542ACTIVELIFE0227642018-11-16
00768455101559ACTIVELIFE0227652018-11-16
00768455101566ACTIVELIFE0227662018-11-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00768455204533ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204540ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204618ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204625ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204632ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204649ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204656ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204663ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
00768455204670ESTEEMCONVATEC, PURCHASING DEPARTMENTEXH2024-03-20
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00610075000982PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075000999PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075001002PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039180PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039197PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039210PremierHOLLISTER INCORPORATEDEXG2022-12-01
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00610075039319PremierHOLLISTER INCORPORATEDEXG2022-12-01
00610075039326PremierHOLLISTER INCORPORATEDEXG2022-12-01
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00610075064441PremierHOLLISTER INCORPORATEDEXG2022-12-01