Device
24" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched), MDR
Manufacturer
APPLIED MEDICAL TECHNOLOGY, INC.
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