AMT Guidewire Compatible Balloon Stoma Measurement Device E1804, 1804

GUDID 00842071133238

Guidewire Compatible Balloon Stoma Measuring Device (Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy depth sizer

• Primary Device ID: 00842071133238
• NIH Device Record Key: 53cfd9fc-54d6-4ea5-bf45-3f3bcb0b4e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Guidewire Compatible Balloon Stoma Measurement Device
• Version Model Number: E1804
• Catalog Number: E1804, 1804
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00842071133221 [Primary]
GS1	00842071133238 [Package]; Contains: 00842071133221; Package: Box (1804) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973893

FDA Product Code

• KNT: Tubes, Gastrointestinal (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: 2024-08-05
• Device Publish Date: 2024-07-26

On-Brand Devices [AMT Guidewire Compatible Balloon Stoma Measurement Device]

• 00842071106836: Guidewire Compatible Balloon Stoma Measuring Device (Pouched)
• 00842071133238: Guidewire Compatible Balloon Stoma Measuring Device (Pouched), MDR