Device
Two-Way
Manufacturer
AMSINO INTERNATIONAL, INC.
Model: 1 Catalog: AS41014HC DI: 10704411017097 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: Yes OTC: No
First Published: 2026-05-15 Current Version: 2026-05-25
Description
Two-Way 14FR 5cc 16” Coude tip
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: b5e9dcd3-0712-4ec3-8637-326952aa2a85
Distribution Status: In Commercial Distribution
DUNS Number: 825673239
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: Yes
Labeled No NRL: No
Identifiers
Item #1 - Pkg Type: Box
Item #1 - Device ID: 30704411017091
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10704411017097
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10704411017097
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
Item #3 - Pkg Type: Case
Item #3 - Device ID: 40704411017098
Item #3 - Pkg Status: In Commercial Distribution
Item #3 - Pkg Quantity: 20
Item #3 - Device ID Type: Package
Item #3 - Contains DINumber: 30704411017091
Item #3 - Device ID 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
Premarket Submissions
Submission Number: K091699
Supplement Number: 000