FDA.reportPublic FDA data

Hollister

Primary DI
00610075105618
Brand
Hollister
Company
HOLLISTER INCORPORATED
Model
9839
Catalog number
9839
Device description
Urinary Night Drainage Bag - STERILE Fluid Pathway
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYZSYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075105612PackageGS11In Commercial Distribution
00610075105618PrimaryGS10
00610075090761Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2061007510561220610075105612
00610075105618006100751056186100751056180610075105618
00610075090761006100750907616100750907610610075090761

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable adult urine collection bag, open-endedA flexible plastic pouch designed to connect to a urinary catheter or a urinary condom catheter to collect discharged urine from an adult/adolescent patient; it is designed with an opening for urine drainage. The device is not directly attached to the patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
20
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
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
00610075096633VaPro Plus Pocket Kit79169K79169K2025-01-24
00610075102082Advance Plus96064IC96064IC2016-09-21
00610075102099Advance Plus96084IC96084IC2016-09-21
00610075102105Advance Plus96104IC96104IC2016-09-21
00610075102112Advance Plus96124IC96124IC2016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118607346ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00840118611930ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
20610075093469HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096453HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096552HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075105612HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
10080196028863MEDLINEMEDLINE INDUSTRIES, INC.EYZ2022-01-16
36641670005589SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
36641670005626SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
16641670005578SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
16641670005615SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
00810050241137N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
00810050242202N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
05055788767459EZ-Flow Catheter ValveFLEXICARE MEDICAL LIMITEDEYZ2020-03-25
20686864042956AMD-RITMEDAMD Medicom IncEYZ2019-01-24
20686864042963AMD-RITMEDAMD Medicom IncEYZ2019-01-24
10884521003446DoverCardinal Health, Inc.EYZ2018-06-27
10884521003453DoverCardinal Health, Inc.EYZ2018-06-27
20884521003443DoverCardinal Health, Inc.EYZ2018-06-27
20884521003450DoverCardinal Health, Inc.EYZ2018-06-27
10080196028856MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183012MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183401MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183418MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183531MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196028857MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183013MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183402MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196028825MedlineMEDLINE INDUSTRIES, INC.EYZ2016-09-29
10080196028894MedlineMEDLINE INDUSTRIES, INC.EYZ2016-09-29