FDA.reportPublic FDA data

New Image

Primary DI
20610075181531
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
18153
Catalog number
18153
Device description
2-Piece Ostomy Irrigator Sleeve
Published
2022-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXDIrrigator, ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXDIrrigator, OstomyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075181531PackageGS124In Commercial Distribution
00610075181537PrimaryGS10
00610075083787Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007518153120610075181531
00610075181537006100751815376100751815370610075181537
00610075083787006100750837876100750837870610075083787

GMDN Terms#

Term, Definition table
TermDefinition
Colostomy irrigation kit, single-useA collection of non-sterile devices designed to wash out the colon through a colostomy site. It typically includes a container of fluid, tubing with a cone-shaped tip, or a soft and flexible catheter with a retention shield. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter57Millimeter

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
00610075040070InstaFlo330162016-09-21
00610075179626ActiFlo320042016-09-21
00610075179633ActiFlo320052016-09-21
00610075179640ActiFlo320062016-09-21
00610075179657ActiFlo320072016-09-21
10610075180292Advance Plus Pocket93104IC93104IC2016-09-21
10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
10610075180315Advance Plus Pocket93144IC93144IC2016-09-21
10610075180322Advance Plus Pocket93164IC93164IC2016-09-21
00610075077243Hollister772477242022-12-01
00610075077281Hollister772877282022-12-01
00610075095667VaPro Plus Pocket Kit79089K79089K2024-07-15
00610075095674VaPro Plus Pocket Kit79109K79109K2024-07-15
00610075095681VaPro Plus Pocket Kit79129K79129K2024-07-15
00610075095698VaPro Plus Pocket Kit79149K79149K2024-07-15
00610075095704VaPro Plus Pocket Kit79169K79169K2024-07-15
00610075096541VaPro Plus Pocket Kit79089K79089K2025-01-24
00610075096602VaPro Plus Pocket Kit79109K79109K2025-01-24
00610075096619VaPro Plus Pocket Kit79129K79129K2025-01-24
00610075096626VaPro Plus Pocket Kit79149K79149K2025-01-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842071136642MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136659MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136666MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136673MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136680MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136697MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136703MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136710MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136727MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136734MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136741MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136758MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136765MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136772MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136789MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136796MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136802MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136819MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136826MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136833MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136840MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136857MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136864MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136871MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136888MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136895MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136901MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136918MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136925MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30
00842071136932MiniACEAPPLIED MEDICAL TECHNOLOGY, INC.EXD2024-08-30