FDA.reportPublic FDA data

Assura

Primary DI
00762123031438
Brand
Assura
Company
Coloplast A/S
Model
5570
Catalog number
5570
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
00762123031438PackageGS110In Commercial Distribution
00762123031421PrimaryGS10
05701780030885Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00762123031438007621230314387621230314380762123031438
00762123031421007621230314217621230314210762123031421
05701780030885057017800308855701780030885

GMDN Terms#

Term, Definition table
TermDefinition
One-piece urostomy bag, open-endedA one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. 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
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 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