FDA.reportPublic FDA data

Safe N Simple

Primary DI
00810040133138
Brand
Safe N Simple
Company
SAFE N' SIMPLE LLC
Model
SNS7501134
Catalog number
SNS7501134
Device description
"9"" Urostomy 2-Piece Pouch Beige 45 mm 1 3/4"" Flange with Valve and Belt Tabs"
Published
2023-11-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXGBag, Urine Collecting, Ureterostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040133138PrimaryGS10
00810040133114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040133138008100401331388100401331380810040133138
00810040133114008100401331148100401331140810040133114

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length9Inch

Contacts#

Phone, Email table
PhoneEmail
248 214 4877amy@sns-medical.com

Regulatory Flags#

DUNS number
807812412
Device count
80
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810040130403Safe N Simple LLCSNS684D2SNS684D22026-10-15
00810040130410Safe N Simple LLCSNS684D2SNS684D22026-10-15
00810040130496Safe N Simple LLCSNS21615SNS216152026-10-15
00810040130502Safe N Simple LLCSNS21615SNS216152026-10-15
00810040134265Safe N Simple LLCSNS7135005SNS71350052026-10-15
00810040134296Safe N Simple LLCSNS7126049SNS71260492026-10-15
00810040134302Safe N Simple LLCSNS7135005SNS71350052026-10-15
00810040134326Safe N Simple LLCSNS7153005SNS71530052026-10-15
00810040134333Safe N Simple LLCSNS7153005SNS71530052026-10-15
00810040135583Safe N Simple LLCSNS21222SNS212222026-10-15
00810040135590Safe N Simple LLCSNS21222SNS212222026-10-15
00810040135613Safe N Simple LLCSNS21630SNS216302026-10-15
00810040135620Safe N Simple LLCSNS21630SNS216302026-10-15
00810040135644Safe N Simple LLCSNS21113SNS211132026-10-15
00810040135651Safe N Simple LLCSNS21113SNS211132026-10-15
00810040135675Safe N Simple LLCSNS68112SNS681122026-10-15
00810040135682Safe N Simple LLCSNS68112SNS681122026-10-15
00850002835007Safe N Simple LLCSNS14506SNS145062026-10-15
00850002835014Safe N Simple LLCSNS14506SNS145062026-10-15
00850002835021Safe N Simple LLCSNS14502SNS145022026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970944383757OSTUPMEDJiangsu Ostup Medical Products Co., Ltd.EXG2026-10-09
06974795055948MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795058116MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795059199MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
00810040135170Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135187Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135248Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135255Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135293Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135309Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135163Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135231Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135286Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
06974567745886EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
16974567745883EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204653ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204660ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204677ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204714ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204721ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204745ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204752ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204769ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
00810040133121Safe N SimpleSAFE N' SIMPLE LLCEXG2023-11-01