FDA.reportPublic FDA data

Safe N Simple

Primary DI
00810040134821
Brand
Safe N Simple
Company
SAFE N' SIMPLE LLC
Model
SNS7212134-NF
Catalog number
SNS7212134-NF
Device description
"12"" Drainable 2-Piece Pouch Beige 50 mm 2"" Flange with Belt Tabs and Velcro Closure"
Published
2024-11-08
Public version status
Update
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
EZSAppliance, Colostomy, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZSAppliance, Colostomy, DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040134821PrimaryGS10
00810040134814Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040134821008100401348218100401348210810040134821
00810040134814008100401348148100401348140810040134814

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-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 consists of two or more separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
807812412
Device count
10
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
00850088144574CARBOUNingbo kehu Medical Technology Co.,Ltd.EZS2026-07-09
10661613525006UltraMaxMarlen Manufacturing And Development Co.EZS2026-04-28
30885632431160HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431207HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431214HalyardO&M HALYARD, INC.EZS2025-01-10
30885632431245HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431163HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431200HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431217HalyardO&M HALYARD, INC.EZS2025-01-10
20885632431248HalyardO&M HALYARD, INC.EZS2025-01-10
00860010269800OstohOstoh, LLCEZS2024-12-16
10885632431128HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431135HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431142HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431159HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431227HalyardO&M HALYARD, INC.EZS2024-11-12
10885632431234HalyardO&M HALYARD, INC.EZS2024-11-12
10885632434709HalyardO&M HALYARD, INC.EZS2024-11-12
10885632434716HalyardO&M HALYARD, INC.EZS2024-11-12
30885632431122HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431132HalyardO&M HALYARD, INC.EZS2024-11-12
20885632431149HalyardO&M HALYARD, INC.EZS2024-11-12
10810040134804Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
10810040134828Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134777Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134784Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134807Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134876Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134883Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08
00810040134906Safe N SimpleSAFE N' SIMPLE LLCEZS2024-11-08