Device
24" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched), MDR
Manufacturer
APPLIED MEDICAL TECHNOLOGY, INC.
Model: ES1-2421 Catalog: ES1-2421, S1-2421 DI: 00842071153069 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-28 Current Version: 2026-05-06
Description
24" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched), MDR
Sterilization
Device Sterile: Yes
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 7c6d86d7-fb63-4897-8b94-8bf126c8d558
Distribution Status: In Commercial Distribution
DUNS Number: 038101861
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: Yes
Expiration Date Tracked: Yes
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: Yes
Identifiers
Item #1 - Pkg Type: Box (S1-2421)
Item #1 - Device ID: 00842071153076
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 00842071153069
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 00842071153069
Item #2 - Device ID Type: Primary
Item #2 - Device ID Issuing Agency: GS1
GMDN
Code: 34924
Name: Suprapubic drainage catheter
Definition:
A flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.
FDA Product Codes
KOB
Catheter, Suprapubic (And Accessories)
KNT
Tubes, Gastrointestinal (And Accessories)
Premarket Submissions
Submission Number: K240514
Supplement Number: 000
Device Sizes
Device Size - Size - @attributes - Unit: Inch
Device Size - Size - @attributes - Value: 24
Device Size - Size Type: Length