FDA.reportPublic FDA data

Premier

Primary DI
20610075188639
Brand
Premier
Company
HOLLISTER INCORPORATED
Model
84699
Catalog number
84699
Device description
1-Piece Urostomy Pouch, Flextend
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EXGBAG, URINE COLLECTING, URETEROSTOMY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXGBag, Urine Collecting, UreterostomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075188639PackageGS124In Commercial Distribution
00610075188635PrimaryGS10
00610075082599Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007518863920610075188639
00610075188635006100751886356100751886350610075188635
00610075082599006100750825996100750825990610075082599

GMDN Terms#

Term, Definition table
TermDefinition
One-piece urostomy bag, open-endedA one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma for use as a urine collection device in the management of urinary diversions; it includes a drainage tap to permit the emptying of fluids (open-ended). The entire device is removed when changed. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter44Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
10
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
00610075093427Hollister934293422022-12-01
00610075093434Hollister934393432022-12-01
00610075097807Hollister978097802016-09-21
00610075097814Hollister978197812022-12-01
00610075097821Hollister978297822016-09-21
00610075097142Adapt780578052026-03-13
00610075097159Adapt780678062026-03-13
00610075097166Adapt781578152026-03-13
10610075097149Adapt780578052026-03-13
10610075097156Adapt780678062026-03-13
10610075097163Adapt781578152026-03-13
10610075198617New Image19353193532022-12-01
00610075071630Karaya 5716371632022-12-01
00610075085101Premier851085102022-12-01
00610075085132Premier851385132022-12-01
00610075085286Premier852885282022-12-01
00610075085927Premier859285922022-12-01
00610075173341Premier858485842022-12-01
00610075173365Premier85811858112022-12-01
00610075852116Premier85211852112022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974795055948MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795058116MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
06974795059199MDK-MEDICALHenan Maidingkang Medical Technology Co., Ltd.EXG2025-04-23
00810040135170Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135187Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135248Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135255Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135293Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135309Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135163Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135231Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
00810040135286Safe N SimpleSAFE N' SIMPLE LLCEXG2024-11-08
06974567745886EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
16974567745883EMSRUNWuxi Emsrun Technology Co., Ltd.EXG2024-05-22
10768455204530ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204547ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204615ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204622ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204639ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204646ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204653ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204660ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204677ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204714ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204721ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204745ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204752ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
10768455204769ESTEEMCONVATEC, PURCHASING DEPARTMENTEXG2024-03-20
00810040133121Safe N SimpleSAFE N' SIMPLE LLCEXG2023-11-01
00810040133138Safe N SimpleSAFE N' SIMPLE LLCEXG2023-11-01