AccessGUDID - DEVICE: Actreen® (04046955196685)

GUDID

Device Identifier (DI) Information

Brand Name: Actreen®
Version or Model: 242214NA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 242214NA
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046955196685
Issuing Agency: GS1
Commercial Distribution End Date: July 31, 2021
Device Count: 30
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: Actreen® Hi-Lite Cath Straight Set 37cm 14 Fr

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:	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
GBM	CATHETER, URETHRAL

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
Special Storage Condition, Specify: This way up
Special Storage Condition, Specify: KEEP DRY
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify:

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 14.0 French
Device Size Text, specify: Charrière (catheter) : 14.000
Outer Diameter: 4.7 Millimeter
Length: 37 Centimeter

Device Record Status

Public Device Record Key: b2245ef0-bbb9-4734-9c56-49befdde7be4
Public Version Date: August 25, 2025
Public Version Number: 5
DI Record Publish Date: March 03, 2019