FDA.report

Conveen

Primary DI
05708932640329
Brand
Conveen
Company
Coloplast A/S
Model
5070
Catalog number
5070
Published
2022-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NNWBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Product Code Classifications

CodeDeviceSpecialtyClass
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708932640329PackageGS1100In Commercial Distribution
05708932640312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708932640329057089326403295708932640329
05708932640312057089326403125708932640312

GMDN Terms

TermDefinition
Non-wearable urine/faecal collection bag holderA device designed to secure a urine or faecal collection bag (e.g., intestinal ostomy bag), or a respective bag extension, in a stable position and height to an object other than the patient. It is available in a variety of designs (e.g., hanger) and may be intended to attach the bag to objects such as wheelchairs, beds, and chairs occupied by the patient, or it may be a freestanding device with bag-suspending hooks/clips (e.g., portable stand). This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
305524696
Device count
1
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

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03600040963876ColoplastAC5904AC59042026-01-30
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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

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