FDA.report

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Primary DI
10610075062529
Brand
New Image
Company
HOLLISTER INCORPORATED
Model
19802
Catalog number
19802
Device description
Colostomy/Ileostomy Kit, CeraPlus
Published
2022-12-01
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

Contact Domains

Product Codes

CodeName
PQEOstomy care kit

Product Code Classifications

CodeDeviceSpecialtyClass
PQEOstomy Care KitGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10610075062529PackageGS112In Commercial Distribution
00610075062522PrimaryGS10
20610075062526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007506252910610075062529
00610075062522006100750625226100750625220610075062522
2061007506252620610075062526

GMDN Terms

TermDefinition
Urostomy bag/support kitA collection of devices intended to be used for attachment/replacement of a urostomy bag (for collecting urine following a urostomy procedure). It includes not only the urostomy bag and base plate, but also additional ostomy fitting/maintenance supportive devices (e.g., towels, wipes, scissors). This is a single-use device.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter32Millimeter
Lumen/Inner Diameter44Millimeter

Sterilization Methods

Method

Contacts

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
true
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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
10610075095732HollisterHOLLISTER INCORPORATEDPQE2024-10-01
10610075095749HollisterHOLLISTER INCORPORATEDPQE2024-10-01
10610075095756HollisterHOLLISTER INCORPORATEDPQE2024-10-01
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06948909401334BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-08-03
06948909401341BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-08-03
06948909401358BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-08-03
06948909401365BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-08-03
06948909401372BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-08-03
06948909401389BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-08-03
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06959385758317ZDZhende Medical Co., Ltd.PQE2023-07-05
06948909401297BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-06-28
06948909401310BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-06-28
06948909401327BynexShaoxing Haoshide Medical Products Co., Ltd.PQE2023-06-28
06926515406400BynexZhende Medical Co., Ltd.PQE2023-06-22
10768455198129NATURACONVATEC, PURCHASING DEPARTMENTPQE2023-04-24
00768455198139NATURACONVATEC, PURCHASING DEPARTMENTPQE2023-04-24
00768455198146NATURACONVATEC, PURCHASING DEPARTMENTPQE2023-04-24