FDA.reportPublic FDA data

NATURA

Primary DI
10768455105691
Brand
NATURA
Company
CONVATEC, PURCHASING DEPARTMENT
Model
411292
Device description
SUR-FIT Natura® Drainable Pouch, 10" Opaque, 2 Side Flocking, With Filter 2 3/4"
Published
2022-09-28
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
EZQPOUCH, COLOSTOMY
FONBag, drainage, with adhesive, ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZQPouch, ColostomyGastroenterology, Urology1
FONBag, Drainage, With Adhesive, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10768455105691PackageGS120In Commercial Distribution
00768455105694PrimaryGS10
00768455186075Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076845510569110768455105691
00768455105694007684551056947684551056940768455105694
00768455186075007684551860757684551860750768455186075

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-piece urostomy bag, open-endedA plastic pouch composed of two or more parts [e.g., a barrier (wafer) and a pouch; both having flange/locking mechanisms] designed to attach to a patient's skin around a stoma for use as a urinary collection device in the management of urinary diversions. It has a non-return valve to prevent urine from pooling at the base of the stoma. It also has a drainage tap to permit the emptying of fluids. The barrier (wafer) remains attached around the stoma when the bag is removed/changed. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
809784593
Device count
20
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
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
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00850088144352CARBOUNingbo kehu Medical Technology Co.,Ltd.FON2026-07-10
00850088144369CARBOUNingbo kehu Medical Technology Co.,Ltd.FON2026-07-10
00850088144123CARBOUNingbo kehu Medical Technology Co.,Ltd.FON2026-07-09
00850088144376CARBOUNingbo kehu Medical Technology Co.,Ltd.FON2026-07-08
00850087488501CeeportCEEPORT INC.FON2026-05-29
B674WIKB1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB1402101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKB2001101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE1401101PerilavStiehl Tech, LLCFON2026-05-13
B674WIKE2001101PerilavStiehl Tech, LLCFON2026-05-13
16937359412394MaidwocWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2023-04-19
16937359412387Steawoce Wuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-21
16937359412370SteawoceWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-15
16937359412356SteadliveWuhan Sitaili Medical Apparatus Development Co., Ltd.FON2022-12-07
00768455102549ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-29
00768455105670NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-29
00768455102518ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455102525ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455102532ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455102556ACTIVE LIFECONVATEC, PURCHASING DEPARTMENTFON2022-09-28
00768455102563ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455102570ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455102587ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455102594ACTIVELIFECONVATEC, PURCHASING DEPARTMENTEZQ2022-09-28
00768455105618NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-28
00768455105625NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-28
00768455105632NATURACONVATEC, PURCHASING DEPARTMENTFON2022-09-28