FDA.reportPublic FDA data

Advance Plus

Primary DI
00610075102143
Brand
Advance Plus
Company
HOLLISTER INCORPORATED
Model
96184IC
Catalog number
96184IC
Device description
Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 18 Fr 16 in
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHRCatheter care tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075102140PackageGS14In Commercial Distribution
00610075102143PrimaryGS10
30610075102144Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007510214010610075102140
00610075102143006100751021436100751021430610075102143
3061007510214430610075102144

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0
Length0

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
25
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

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
10198459678653MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678660MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678677MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678684MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459678691MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
10198459679025MEDLINEMEDLINE INDUSTRIES, INC.OHR2026-07-31
00850067913023TruCath®HR PHARMACEUTICALS INC.OHR2026-07-23
10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
00610075096541VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096602VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096619VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096626VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075096633VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2025-01-24
00610075095667VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095674VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095681VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095698VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
00610075095704VaPro Plus Pocket KitHOLLISTER INCORPORATEDOHR2024-07-15
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
10193489834482MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
10080196997084MedlineMEDLINE INDUSTRIES, INC.OHR2023-12-28
10195327468880Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-12-21
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17