FDA.reportPublic FDA data

Premier

Primary DI
10610075155849
Brand
Premier
Company
HOLLISTER INCORPORATED
Model
82302
Device description
One-Piece Mini Closed Oval Cut-to-Fit Pouch, no tape with Filter, SoftFlex skin barrier, Beige, up to 75mm x 65mm, 3"x2-1/2"
Published
2018-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10610075155849PackageGS112In Commercial Distribution
00610075155842PrimaryGS10
00610075079247Unit of UseGS10
20610075155846Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007515584910610075155849
00610075155842006100751558426100751558420610075155842
00610075079247006100750792476100750792470610075079247
2061007515584620610075155846

GMDN Terms#

Term, Definition table
TermDefinition
One-piece urostomy bagA one-piece plastic pouch designed to be attached with adhesive to a patient's skin around a stoma to be used as a urine collection device in the management of urinary diversions. The entire device is removed when the bag is emptied. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height65Millimeter
Length9Inch
Length23Centimeter
Lumen/Inner Diameter75Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
30
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
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00610075029846New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029853New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029860New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029877New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029884New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029891New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029907New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029914New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075029921New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075031849HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075031863HollisterHOLLISTER INCORPORATEDEXB2022-12-01
00610075033263Karaya 5HOLLISTER INCORPORATEDEXB2022-12-01
00610075037742PouchkinsHOLLISTER INCORPORATEDEXB2022-12-01
00610075051762New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051779New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051786New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051793New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051809New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051816New ImageHOLLISTER INCORPORATEDEXB2022-12-01
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00610075051830New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051847New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051854New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051861New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051984New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075051991New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075052004New ImageHOLLISTER INCORPORATEDEXB2022-12-01
00610075052011New ImageHOLLISTER INCORPORATEDEXB2022-12-01