Hollister

Primary DI
20610075093483
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9348
Catalog number
9348
Device description
Urinary Leg Bag Combination Pack
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNWBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNWBag, Urine Collection, Leg, For External Use, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075093483PackageGS12In Commercial Distribution
00610075093489PrimaryGS10
00610075071289Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007509348320610075093483
00610075093489006100750934896100750934890610075093489
00610075071289006100750712896100750712890610075071289

GMDN Terms#

Term, Definition table
TermDefinition
Wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter and to be strapped to or worn on the leg of an adult/adolescent patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume540Milliliter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
12
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
true
Sterilization required before use
false

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10610075180308Advance Plus Pocket93124IC93124IC2016-09-21
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00610075096619VaPro Plus Pocket Kit79129K79129K2025-01-24
00610075096626VaPro Plus Pocket Kit79149K79149K2025-01-24

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00610075093427HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093434HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093458HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093489HollisterHOLLISTER INCORPORATEDNNW2022-12-01
00610075093496HollisterHOLLISTER INCORPORATEDNNW2022-12-01