FDA.report

Assura

Primary DI
00762123032503
Brand
Assura
Company
Coloplast A/S
Model
14165
Catalog number
14165
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

Related Records

Contact Domains

Product Codes

CodeName
EXBCOLLECTOR, OSTOMY

Product Code Classifications

CodeDeviceSpecialtyClass
EXBCollector, OstomyGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00762123032503PackageGS116In Commercial Distribution
00762123032428PrimaryGS10
05701780102612Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123032503007621230325037621230325030762123032503
00762123032428007621230324287621230324280762123032428
05701780102612057017801026125701780102612

GMDN Terms

TermDefinition
One-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 is a one-piece device, typically having a self-adhesive flange, that is removed and disposed of in accordance with the clinician's instructions. The distal end of the pouch can be opened for drainage of the waste (average of 400-800 ml per day) and emptied several times per day. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags

DUNS number
305524696
Device count
10
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 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 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