AMT MiniSPC Drainage Set

Basic Information

• Brand Name: AMT MiniSPC Drainage Set
• Primary DI: 00842071148331
• Version / Model: ES1-1221
• Catalog Number: ES1-1221, S1-1221
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 038101861
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-24
• Public Version: 1
• Public Version Date: 2025-02-03
• Public Version Status: New
• Public Device Record Key: ba1c14a4-00be-4eea-95b3-a52148cab5cf

Device Description

12" Right Angle Drainage Set - For Use with the MiniSPC Button (Pouched)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOB	Catheter, Suprapubic (And Accessories)	Gastroenterology, Urology	876.5090	2
KNT	Tubes, Gastrointestinal (And Accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34924	Suprapubic drainage catheter	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00842071148348	GS1	Box (S1-1221)	10	In Commercial Distribution
Primary	00842071148331	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K240514	000

Device Sizes

Type	Value	Unit	Text
Length	12	Inch