FDA.reportPublic FDA data

Brava

Primary DI
05708932504218
Brand
Brava
Company
Coloplast A/S
Model
4215
Catalog number
4215
Device description
Brava Belt . More discreet. Ostomy Care.
Published
2022-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
true
Sterile
false
Single use
false

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
05708932504201PackageGS115In Commercial Distribution
05708932504218PackageGS18In Commercial Distribution
05708932504195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708932504201057089325042015708932504201
05708932504218057089325042185708932504218
05708932504195057089325041955708932504195

GMDN Terms#

Term, Definition table
TermDefinition
Ostomy bag pressure bandageA piece, strip, or band of material designed to apply pressure to stabilize an ostomy bag (receptacle that collects bodily waste through a stoma) to a patient's body. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708932125338SpeediCath Flex Coude Pro20012200122019-07-12
05708932125369SpeediCath Flex Coude Pro20014200142019-07-12
05701780348317Luja Soft20171201712026-10-01
05701780348348Luja Soft20172201722026-10-01
05701780348379Luja Soft20174201742026-10-01
05701780348409Luja Soft20176201762026-10-01
05701780265058Biatain Adhesive348834882026-08-27
05708932787109Titan PrimeDS3918DS39182026-08-14
05708932787116Titan PrimeDS3920DS39202026-08-14
05708932787123Titan PrimeDS3922DS39222026-08-14
05708932787130Titan Prime5400055400052026-08-14
05708932787147Titan Prime5400105400102026-08-14
05708932787888Titan Prime5400155400152026-08-14
05708932787925Titan Prime5400205400202026-08-14
05708932787963Titan Prime5400255400252026-08-14
05708932788007Titan Prime5400305400302026-08-14
05708932788045Titan Prime5400405400402026-08-14
05708932788083Titan Prime5400505400502026-08-14
00762123030196Conveen Security+21346213462022-03-11
05701780385411SenSura Mio Convex18541185412026-06-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00610075052011New ImageHOLLISTER INCORPORATEDEXB2022-12-01