FDA.reportPublic FDA data

SenSura

Primary DI
00762123051306
Brand
SenSura
Company
Coloplast A/S
Model
15480
Catalog number
15480
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00762123051306PackageGS18In Commercial Distribution
00762123051290PrimaryGS10
05701780129305Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123051306007621230513067621230513060762123051306
00762123051290007621230512907621230512900762123051290
05701780129305057017801293055701780129305

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags#

DUNS number
305524696
Device count
30
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
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05701780415583SenSura MioColoplast A/SEXB2026-01-21
05701780416320SenSura MioColoplast A/SEXB2026-01-21
05701780418263SenSura MioColoplast A/SEXB2026-01-21
05701780419154SenSura MioColoplast A/SEXB2026-01-21
05701780420099SenSura MioColoplast A/SEXB2026-01-21
05701780421065SenSura MioColoplast A/SEXB2026-01-21
05701780357371SenSura MioColoplast A/SEXB2025-11-20
05701780357432SenSura MioColoplast A/SEXB2025-11-20
05701780357494SenSura MioColoplast A/SEXB2025-11-20
05701780357555SenSura MioColoplast A/SEXB2025-11-20
05701780357616SenSura MioColoplast A/SEXB2025-11-20
05701780357678SenSura MioColoplast A/SEXB2025-11-20
05701780357739SenSura MioColoplast A/SEXB2025-11-20
05701780358033SenSura MioColoplast A/SEXB2025-11-20
05701780358071SenSura MioColoplast A/SEXB2025-11-20
05701780358101SenSura MioColoplast A/SEXB2025-11-20
05701780358149SenSura MioColoplast A/SEXB2025-11-20
05701780358187SenSura MioColoplast A/SEXB2025-11-20
05701780358217SenSura MioColoplast A/SEXB2025-11-20
05701780359504SenSura MioColoplast A/SEXB2025-11-20
05701780359627SenSura MioColoplast A/SEXB2025-11-20
05701780359689SenSura MioColoplast A/SEXB2025-11-20
05701780356084SenSura MioColoplast A/SEXB2025-04-25
05701780356145SenSura MioColoplast A/SEXB2025-04-25
05701780356206SenSura MioColoplast A/SEXB2025-04-25
05701780356268SenSura MioColoplast A/SEXB2025-04-25
05701780356329SenSura MioColoplast A/SEXB2025-04-25
05701780359948SenSura MioColoplast A/SEXB2025-04-25
05701780360029SenSura MioColoplast A/SEXB2025-04-25
05701780360050SenSura MioColoplast A/SEXB2025-04-25