AMT Balloon Measuring Device E1904, 1904

GUDID 00842071152963

Guidewire Compatible Balloon Measuring Device (Pouched), MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Medical ruler, single-use

• Primary Device ID: 00842071152963
• NIH Device Record Key: 9deb1766-292b-4864-bd5a-c38294eca977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Balloon Measuring Device
• Version Model Number: E1904
• Catalog Number: E1904, 1904
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071152956 [Primary]
GS1	00842071152963 [Package]; Contains: 00842071152956; Package: Box (1904) [10 Units]; In Commercial Distribution

FDA Product Code

• FTY: Tape, Measuring, Rulers And Calipers

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: 2026-03-02
• Device Publish Date: 2026-02-20

Devices Manufactured by APPLIED MEDICAL TECHNOLOGY, INC.

• 00842071152963 - AMT Balloon Measuring Device: 2026-03-02Guidewire Compatible Balloon Measuring Device (Pouched), MDR
• 00842071152963 - AMT Balloon Measuring Device: 2026-03-02 Guidewire Compatible Balloon Measuring Device (Pouched), MDR
• 00842071146412 - MINI Balloon Button: 2026-02-23 16FR x 2.0 cm MINI Balloon Button Kit, MDR
• 00842071146429 - MINI Balloon Button: 2026-02-23 16FR x 2.0 cm MINI Balloon Button Kit (ENFit), MDR
• 00842071146238 - MINI Balloon Button: 2026-01-06 14FR x 4.4 cm MINI Balloon Button Kit, MDR
• 00842071146245 - MINI Balloon Button: 2026-01-06 14FR x 4.4 cm MINI Balloon Button Kit (ENFit), MDR
• 00842071146252 - MINI Balloon Button: 2026-01-06 14FR x 5.0 cm MINI Balloon Button Kit, MDR
• 00842071146269 - MINI Balloon Button: 2026-01-06 14FR x 5.0 cm MINI Balloon Button Kit (ENFit), MDR
• 00842071145798 - MINI Balloon Button: 2025-11-24 12FR x 1.2 cm MINI Balloon Button Kit, MDR