ESTEEM+

Primary DI
10768455115355
Brand
ESTEEM+
Company
CONVATEC, PURCHASING DEPARTMENT
Model
416976
Device description
Esteem®+ One-Piece Drainable Extended Wear Cut-To-Fit Pouch W/ Invisiclose®, Durahesive Plus, Filter, One-Sided Comfort Panel, 12" Clear, 2 1/2 In (64Mm)
Published
2022-09-29
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

Related Records

Contact Domains

Product Codes

CodeName
EZQPOUCH, COLOSTOMY
FONBag, drainage, with adhesive, ostomy

Product Code Classifications

CodeDeviceSpecialtyClass
EZQPouch, ColostomyGastroenterology, Urology1
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455115355PackageGS114In Commercial Distribution
00768455115358PrimaryGS10
00768455189045Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845511535510768455115355
00768455115358007684551153587684551153580768455115358
00768455189045007684551890457684551890450768455189045

GMDN Terms

TermDefinition
One-piece intestinal ostomy bag, open-endedA plastic pouch designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+18004228811cic@convatec.com
+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

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