Apogee Plus

Basic Information

• Brand Name: Apogee Plus
• Primary DI: 20610075177183
• Version / Model: B16FB
• Catalog Number: B16FB
• Company Name: HOLLISTER INCORPORATED
• Labeler DUNS: 005527098
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 6
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: b1f61a87-30fa-4333-b5d8-e650e9e548a4

Device Description

Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 16 Fr 16 in, Firm, Straight

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)	Gastroenterology, Urology	876.5130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45603	Single-administration urethral drainage catheter	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20610075177183	GS1
Unit of Use	10610075177186	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K032710	000

Device Sizes

Type	Value	Unit	Text
Length	16	Inch
Catheter Gauge	16	French