FDA.reportPublic FDA data

Advance Plus

Primary DI
10610075102133
Brand
Advance Plus
Company
HOLLISTER INCORPORATED
Model
96164IC
Device description
Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 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
FCMTray, catheterization, sterile urethral, with or without catheter (kit)
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)Gastroenterology, Urology2
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013483000INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KITHollister, Inc.2002-01-14KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10610075102133PackageGS14In Commercial Distribution
00610075102136PrimaryGS10
30610075102137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061007510213310610075102133
00610075102136006100751021366100751021360610075102136
3061007510213730610075102137

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length16Inch

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
005527098
Device count
25
DM exempt
false
Premarket exempt
false
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
00610075096121VaPro73124731242026-08-13
00610075096138VaPro73144731442026-08-13
00610075096145VaPro73164731642026-08-13
00610075096152VaPro77124771242026-06-06
00610075096169VaPro77144771442026-06-06
00610075096176VaPro77164771642026-06-06
10610075029539CalciCare529937R529937R2022-12-01
10610075029546CalciCare529938R529938R2022-12-01
10610075029553CalciCare529939R529939R2022-12-01
10610075029560CalciCare529940R529940R2022-12-01
10610075029577CalciCare529967R529967R2022-11-01
10610075029584CalciCare529968R529968R2022-11-01
10610075029591CalciCare529969R529969R2022-11-01
10610075077158m9771577152022-12-01
10610075077172m9771777172022-12-01
10610075077325m9773277322022-12-01
10610075077332m9773377332022-12-01
10610075077349m9773477342022-12-01
10610075077356m9773577352022-12-01
10610075077363m9773677362022-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704925732RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925749RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925763RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925770RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925787RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
14026704925947RUSCHTELEFLEX INCORPORATEDKOD2026-07-28
10192253071078DoverCardinal Health 200, LLCFCM2026-06-24
10192253071115DoverCardinal Health 200, LLCFCM2026-06-24
10192253071122DoverCardinal Health 200, LLCFCM2026-06-24
10192253031782DoverCardinal Health 200, LLCKOD2026-06-18
10192253024258DoverCardinal Health 200, LLCKOD2026-03-20
10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
10192253024272DoverCardinal Health 200, LLCKOD2026-03-20
10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253069549DoverCardinal Health 200, LLCFCM2026-01-20
10192253068535DoverCardinal Health 200, LLCFCM2026-01-16
10192253068542DoverCardinal Health 200, LLCFCM2026-01-16
10192253068559DoverCardinal Health 200, LLCFCM2026-01-16
10192253068566DoverCardinal Health 200, LLCFCM2026-01-16
10192253068573DoverCardinal Health 200, LLCFCM2026-01-16
10192253068580DoverCardinal Health 200, LLCFCM2026-01-16
10192253068597DoverCardinal Health 200, LLCFCM2026-01-16
10192253068610DoverCardinal Health 200, LLCFCM2026-01-16
10192253068665DoverCardinal Health 200, LLCFCM2026-01-16
10192253068702DoverCardinal Health 200, LLCFCM2026-01-16
10192253067958DoverCardinal Health 200, LLCFCM2026-01-15
10192253067996DoverCardinal Health 200, LLCFCM2026-01-15
10192253068009DoverCardinal Health 200, LLCFCM2026-01-15
10192253070859DoverCardinal Health 200, LLCFCM2026-01-15
10192253027754DoverCardinal Health 200, LLCFCM2025-12-10