Model: ESC1610CT
DI: 00850029182023
Status: New
MRI: MR Conditional
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
85949491-f447-479f-96f9-5edb2a38252a
Distribution Status:
In Commercial Distribution
DUNS Number:
117896929
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850029182023
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 34917
Name: Indwelling urethral drainage balloon catheter, non-antimicrobial
Definition:
A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.
FDA Product Codes
EZL
Catheter, Retention Type, Balloon
SCT
Foley Catheters And Accessories With Additional Safety Features
Premarket Submissions
Submission Number:
K241424
Supplement Number:
000
Device Sizes
Item #1 - Size - @attributes - Unit:
French
Item #1 - Size - @attributes - Value:
16
Item #1 - Size Type:
Catheter Gauge
Item #2 - Size - @attributes - Unit:
Milliliter
Item #2 - Size - @attributes - Value:
10
Item #2 - Size Type:
Total Volume