FDA.reportPublic FDA data

CONVATEC

Primary DI
00768455107186
Brand
CONVATEC
Company
CONVATEC, PURCHASING DEPARTMENT
Model
175507
Device description
Ostomy Appliance Belt, Adjustable, 42 Mm
Published
2019-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXEProtector, ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXEProtector, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455107183PackageGS112In Commercial Distribution
00768455107186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510718310768455107183
00768455107186007684551071867684551071860768455107186

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy appliance beltAn adjustable and/or elastic, strip-like device intended to secure an ostomy appliance [e.g., bag, irrigation sleeve] (not included) to a patient’s stoma (e.g., in the intestine/colon) during use. The appliance is attached to the device which is worn by the patient; the device does not include an attachment flange, plate, or ring and is not intended to protect the ostomy site or appliance (i.e., does not include a shield). It is typically made of synthetic polymer materials and is intended for use in the home and healthcare facility. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length107Centimeter

Contacts#

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

Regulatory Flags#

DUNS number
809784593
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00768455145836FLEXI-SEAL4217032019-11-18
00768455157150FLEXI-SEAL4223032019-11-18
00768455185924FLEXI-SEAL4111082022-09-09
00768455209620FLEXI-SEAL4238542023-08-16
30768455143017FLEXI-SEAL4216304216302017-04-26
00768455108565FLEXI-SEAL4111004111002016-09-01
00768455109852FLEXI-SEAL4111004111002016-09-01
00768455117178FLEXI-SEAL4180002016-09-01
00768455143016FLEXI-SEAL4216302017-05-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810226441545ViveVIVE HEALTH LLCEXE2026-08-03
00810226441552ViveVIVE HEALTH LLCEXE2026-08-03
00610075099115CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099122CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099139CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099146CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099153CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075099160CeraPlusHOLLISTER INCORPORATEDEXE2026-05-29
00610075097142AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097159AdaptHOLLISTER INCORPORATEDEXE2026-03-13
00610075097166AdaptHOLLISTER INCORPORATEDEXE2026-03-13
15056276805513EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819060EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819084EakinT.G. EAKIN LIMITEDEXE2026-02-03
15056276819091EakinT.G. EAKIN LIMITEDEXE2026-02-03
00610075097173CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097180CeraPlusHOLLISTER INCORPORATEDEXE2026-01-15
00610075097203AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097210AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075097227AdaptHOLLISTER INCORPORATEDEXE2026-01-15
00610075094752AdaptHOLLISTER INCORPORATEDEXE2024-01-16
00768455108725EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455108732EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109333EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455109340EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455118250EakinT.G. EAKIN LIMITEDEXE2023-05-16
00768455139170EakinT.G. EAKIN LIMITEDEXE2023-05-16
00610075092796CeraPlusHOLLISTER INCORPORATEDEXE2023-05-12
16937359412653SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.EXE2022-12-21
00610075053063AdaptHOLLISTER INCORPORATEDEXE2022-12-01