AccessGUDID - DEVICE: COMPACTCATH - Lite (00852141007406)

GUDID

Device Identifier (DI) Information

Brand Name: COMPACTCATH - Lite
Version or Model: 1011-1614
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1011-1614
Company Name: COMPACTCATH, INC.

Primary DI Number: 00852141007406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 054765780 *Terms of Use

Device Description: The CompactCath Intermittent Urinary Catheter - Lite is a sterile, single-use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
45605	Single-administration urethral catheterization kit, single-use	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EZD	Catheter, Straight

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 14 French

Device Record Status

Public Device Record Key: 00a27c72-ebf8-4c3e-8755-655c95b83b11
Public Version Date: May 02, 2019
Public Version Number: 1
DI Record Publish Date: April 24, 2019