AccessGUDID - DEVICE: SureCath (05708932021128)

GUDID

Device Identifier (DI) Information

Brand Name: SureCath
Version or Model: 28028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28028
Company Name: Coloplast A/S

Primary DI Number: 05708932021128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305524696 *Terms of Use

Device Description: SureCath Set. Urinary catheter with attached bag for intermittent catheterization. Hydrophillic coated catheter. Nelaton. Male. FR 14/4.7 mm. Vol 1200 ml.

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 [?]
K973070	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
Special Storage Condition, Specify: Keep away from sunlight
Special Storage Condition, Specify: Do not use if sterile barrier is damaged

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1200 Milliliter
Device Size Text, specify: Male
Outer Diameter: 4.7 Millimeter
Catheter Gauge: 14 French
Length: 40 Centimeter

Device Record Status

Public Device Record Key: 81862263-8bf8-4e65-b204-cadfa7adf9d7
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 2016