FDA.reportPublic FDA data

Premier

Primary DI
00610075085040
Brand
Premier
Company
HOLLISTER INCORPORATED
Model
8504
Catalog number
8504
Device description
1-Piece Drainable Ostomy Pouch, Convex, Flextend
Published
2022-12-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00610075085040PrimaryGS10
00610075079599Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00610075085040006100750850406100750850400610075085040
00610075079599006100750795996100750795990610075079599

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-4060cs@hollister.com

Regulatory Flags#

DUNS number
005527098
Device count
5
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10610075097149Adapt780578052026-03-13
10610075097156Adapt780678062026-03-13
10610075097163Adapt781578152026-03-13
10610075099440CeraPlus19002C19002C2026-03-01
10610075099457CeraPlus19003C19003C2026-03-01
10610075099471CeraPlus19004C19004C2026-03-01
10610075099488CeraPlus19202C19202C2026-03-01
10610075099495CeraPlus19203C19203C2026-03-01
10610075099501CeraPlus19204C19204C2026-03-01
10610075099518CeraPlus89001C89001C2026-03-01
10610075099525CeraPlus89002C89002C2026-03-01
10610075099600CeraPlus89003C89003C2026-03-01
10610075099617CeraPlus89004C89004C2026-03-01
10610075099624CeraPlus89005C89005C2026-03-01
20610075091922VaPro72082720822026-01-30
20610075092585VaPro72102721022026-01-30
20610075092592VaPro72122721222026-01-30
20610075092608VaPro72142721422026-01-30
20610075092615VaPro72084720842026-01-30
20610075092622VaPro72104721042026-01-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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