FDA.reportPublic FDA data

New Image

Primary DI
10610075132338
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
19102
Catalog number
19102
Device description
Colostomy/Ileostomy Kit, FlexWear
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PQEOstomy care kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PQEOstomy Care KitGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075036282PackageGS112In Commercial Distribution
10610075132338PrimaryGS10
00610075132409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007503628220610075036282
1061007513233810610075132338
00610075132409006100751324096100751324090610075132409

GMDN Terms#

Term, Definition table
TermDefinition
Intestinal ostomy bag/support kitA collection of devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure). It includes not only the intestinal ostomy bag and a base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter32Millimeter
Lumen/Inner Diameter44Millimeter

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
5
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00610075040070InstaFlo330162016-09-21
00610075052332Apogee HC908102016-09-21
00610075052349Apogee HC910062016-09-21
00610075052356Apogee HC910102016-09-21
00610075052363Apogee HC912062016-09-21
00610075052370Apogee HC912162016-09-21
00610075052387Apogee HC914062016-09-21
00610075052394Apogee HC914162016-09-21
00610075052400Apogee HC916162016-09-21
00610075052417Apogee HC918162016-09-21
00610075052424Apogee HC912262016-09-21
00610075052431Apogee HC914262016-09-21
00610075052448Apogee HC916262016-09-21
10610075117250Premier89005890052022-12-01
10610075198631New Image19503195032022-12-01
00610075198443Adapt7730US2018-01-01
00610075198450Adapt7731US2018-01-01
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00610075099443CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099450CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099474CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099481CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099498CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099504CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099511CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099528CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099603CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099610CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075099627CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099440CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099457CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099471CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099488CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099495CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099501CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099518CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099525CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099600CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099617CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
10610075099624CeraPlusHOLLISTER INCORPORATEDPQE2026-03-01
00610075098514New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098521New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098538New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098545New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098569New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075098576New ImageHOLLISTER INCORPORATEDPQE2025-10-10
00610075095735HollisterHOLLISTER INCORPORATEDPQE2024-10-01
00610075095742HollisterHOLLISTER INCORPORATEDPQE2024-10-01