MiniSPC Button SPC-14100-12

GUDID 00842071147341

14F x 10.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set

APPLIED MEDICAL TECHNOLOGY, INC.

Suprapubic drainage catheter

• Primary Device ID: 00842071147341
• NIH Device Record Key: 5873b05e-1745-43fd-b6c0-6814bb10ed97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniSPC Button
• Version Model Number: SPC-14100-12
• Catalog Number: SPC-14100-12
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net
• Phone: (440)717-4000
• Email: cs@appliedmedical.net

Device Dimensions

• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter
• Catheter Gauge: 14 French
• Length: 10 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071147341 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240514

FDA Product Code

• KOB: Catheter, Suprapubic (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-03
• Device Publish Date: 2025-01-24

On-Brand Devices [MiniSPC Button]

• 00842071148324: 18F x 6.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148317: 18F x 6.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148300: 18F x 5.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148294: 18F x 5.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148287: 18F x 5.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148270: 18F x 5.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148263: 18F x 4.4cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148256: 18F x 4.4cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148249: 18F x 4.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148232: 18F x 4.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148225: 18F x 3.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148218: 18F x 3.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148201: 18F x 3.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148195: 18F x 3.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148188: 18F x 2.7cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148171: 18F x 2.7cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148164: 18F x 2.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148157: 18F x 2.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148140: 18F x 2.3cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148133: 18F x 2.3cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148126: 18F x 2.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148119: 18F x 2.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148102: 18F x 1.7cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148096: 18F x 1.7cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148089: 18F x 1.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148072: 18F x 1.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148065: 18F x 1.2cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148058: 18F x 1.2cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148041: 18F x 1.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148034: 18F x 1.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148027: 16F x 6.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071148010: 16F x 6.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071148003: 16F x 5.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147990: 16F x 5.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147983: 16F x 5.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147976: 16F x 5.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147969: 16F x 4.4cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147952: 16F x 4.4cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147945: 16F x 4.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147938: 16F x 4.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147921: 16F x 3.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147914: 16F x 3.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147907: 16F x 3.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147891: 16F x 3.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147884: 16F x 2.7cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147877: 16F x 2.7cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147860: 16F x 2.5cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147853: 16F x 2.5cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147846: 16F x 2.3cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147839: 16F x 2.3cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set