AccessGUDID - DEVICE: FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 14CH (05055788710554)

GUDID

Device Identifier (DI) Information

Brand Name: FEMALE PLAIN INTERMITTENT CATHETER STRAIGHT TIP 14CH
Version or Model: 03-51014U
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FLEXICARE MEDICAL LIMITED

Primary DI Number: 05055788710554
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 504406273 *Terms of Use

Device Description: No description.

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):	No
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?
36125	Urine-sampling urethral catheter	A sterile flexible tube inserted into the bladder, via the urethra, to obtain a sample of urine that has not been contaminated by urethral passage. The distal end can have various tip designs, and the proximal end may terminate in a soft connecting piece to connect to a urine specimen collection container. The device is applied by a healthcare provider to the patient, is typically made of polyvinyl chloride (PVC), and may or may not be coated with a lubricating substance. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOD	Catheter, Urological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132619	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
No Device Sizes

Device Record Status

Public Device Record Key: 42904772-1903-4ad1-9416-5dd5a7f46d7c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 04, 2016