AccessGUDID - DEVICE: Apogee Plus (20610075177107)

GUDID

Device Identifier (DI) Information

Brand Name: Apogee Plus
Version or Model: B12SB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B12SB
Company Name: HOLLISTER INCORPORATED

Primary DI Number: 20610075177107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 005527098 *Terms of Use

Device Description: Pre-lubricated Closed System Intermittent Catheter with Protective Tip and Urine Bag, Kit, 12 Fr 16 in, Soft, Straight

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCM	Tray, catheterization, sterile urethral, with or without catheter (kit)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032710	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 16 Inch
Catheter Gauge: 12 French

Device Record Status

Public Device Record Key: f4668ab5-7504-4a8b-82db-7e53e23c9964
Public Version Date: August 23, 2023
Public Version Number: 6
DI Record Publish Date: September 21, 2016