FDA.report

ESTEEM+

Primary DI
10768455153166
Brand
ESTEEM+
Company
CONVATEC, PURCHASING DEPARTMENT
Model
421848
Device description
Esteem®+ One-Piece Drainable Cut-To-Fit, Clipped, Modified Stomahesive® With Filter, 1 Comfort Panel,Standard 12", Transparent 13/16-2 3/4", 20-70Mm
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
EXHBAG, URINARY, ILEOSTOMY
FONBag, drainage, with adhesive, ostomy

Product Code Classifications

CodeDeviceSpecialtyClass
EXHBag, Urinary, IleostomyGastroenterology, Urology1
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10768455153166PackageGS11In Commercial Distribution
00768455153169PrimaryGS10
00768455172580Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845515316610768455153166
00768455153169007684551531697684551531690768455153169
00768455172580007684551725807684551725800768455172580

GMDN Terms

TermDefinition
One-piece intestinal ostomy bag, closed-endedA plastic pouch designed to be attached with an adhesive to the skin around a faecal stoma and used as a receptacle for faeces following a colostomy [the stool (faeces) being generally well formed]. It is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of when full. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10768455203946ESTEEM4236452024-09-13
10768455209481ESENTA4238272024-08-26
10768455209511ESENTA4238262024-08-26
00768455204793GENTLECATH5106002024-04-05
00768455204823GENTLECATH5106012024-04-05
00768455204854GENTLECATH5106022024-04-05
00768455207145GENTLECATH5106032024-04-05
00768455207169GENTLECATH5106042024-04-05
00768455207206GENTLECATH5106052024-04-05
10815947021172CURE PRODUCTSHM16UK2024-03-30
10768455203922ESTEEM4236432024-03-20
10768455203939ESTEEM4236442024-03-20
10768455203953ESTEEM4236462024-03-20
10768455203960ESTEEM4236472024-03-20
10768455203977ESTEEM4236482024-03-20
10768455204004ESTEEM4236512024-03-20
10768455204011ESTEEM4236522024-03-20
10768455204028ESTEEM4236532024-03-20
10768455204035ESTEEM4236542024-03-20
10768455204059ESTEEM4236562024-03-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06974795051810MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795051896MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795053777MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795054101MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795054736MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795055504MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795056174MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058390MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795058581MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
06974795059632MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXH2025-04-23
10768455105677NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455111913ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455111982ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455111999ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455112033ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455113337NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114815ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114822ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114846ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114853ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114884ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455114891ESTEEM SYNERGY+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455115331ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455115355ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455115720NATURA+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455118127ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455128898NATURA+CONVATEC, PURCHASING DEPARTMENTEXH2022-09-29
10768455130174ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455130181ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29
10768455130198ESTEEM+CONVATEC, PURCHASING DEPARTMENTFON2022-09-29