AMT Clamp™ E4-3000, 4-3000

GUDID 00842071111786

AMT Clamp™ (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

General-purpose catheter connector, sterile

• Primary Device ID: 00842071111786
• NIH Device Record Key: 1aa3f439-ed80-43a9-8ab0-0fae4b72117c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Clamp™
• Version Model Number: E4-3000
• Catalog Number: E4-3000, 4-3000
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net
• Phone: (440) 717-4000
• Email: cs@appliedmedical.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071106874 [Primary]
GS1	00842071111786 [Package]; Contains: 00842071106874; Package: Box (4-3000) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971757

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-09-23

Devices Manufactured by APPLIED MEDICAL TECHNOLOGY, INC.

• 00842071147310 - MiniSPC Button: 2025-02-03 14F x 0.8cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147327 - MiniSPC Button: 2025-02-03 14F x 0.8cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147334 - MiniSPC Button: 2025-02-03 14F x 1.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147341 - MiniSPC Button: 2025-02-03 14F x 10.0cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147358 - MiniSPC Button: 2025-02-03 14F x 10.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147365 - MiniSPC Button: 2025-02-03 14F x 1.0cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set
• 00842071147372 - MiniSPC Button: 2025-02-03 14F x 1.2cm MiniSPC Low Profile Suprapubic Catheter with 12" Drainage Set
• 00842071147389 - MiniSPC Button: 2025-02-03 14F x 1.2cm MiniSPC Low Profile Suprapubic Catheter with 24" Drainage Set