FDA.reportPublic FDA data

Advance Plus Pocket

Primary DI
20610075180305
Brand
Advance Plus Pocket
Company
HOLLISTER INCORPORATED
Model
93124IC
Device description
Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Compact, 12 Fr 16 in, Straight
Published
2016-09-21
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20610075180305PackageGS14In Commercial Distribution
10610075180308PrimaryGS10
30610075180302Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2061007518030520610075180305
1061007518030810610075180308
3061007518030230610075180302

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 Gauge12French
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
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
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10610075097156Adapt780678062026-03-13
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10610075099457CeraPlus19003C19003C2026-03-01
10610075099471CeraPlus19004C19004C2026-03-01
10610075099488CeraPlus19202C19202C2026-03-01
10610075099495CeraPlus19203C19203C2026-03-01
10610075099501CeraPlus19204C19204C2026-03-01
10610075099518CeraPlus89001C89001C2026-03-01
10610075099525CeraPlus89002C89002C2026-03-01
10610075099600CeraPlus89003C89003C2026-03-01
10610075099617CeraPlus89004C89004C2026-03-01
10610075099624CeraPlus89005C89005C2026-03-01
20610075091922VaPro72082720822026-01-30
20610075092585VaPro72102721022026-01-30
20610075092592VaPro72122721222026-01-30
20610075092608VaPro72142721422026-01-30
20610075092615VaPro72084720842026-01-30
20610075092622VaPro72104721042026-01-30

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Primary DI, Brand, Company table
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