AMT Button

GUDID 00842071106591

28 FR 4.3 cm AMT Non Balloon Button (Bard Equivalent)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071106591
• NIH Device Record Key: 52276f02-fd44-4ec9-ac8d-974d83442ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMT Button
• Version Model Number: E1-2843
• 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: 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

Device Dimensions

• Length: 4.3 Centimeter
• Length: 4.3 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071106591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980305

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-09-24

On-Brand Devices [AMT Button]

• 00842071118471: 28 FR 4.3 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118464: 28 FR 2.8 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118457: 28 FR 1.5 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118440: 24 FR 5.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118433: 24 FR 4.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118426: 24 FR 3.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118419: 24 FR 2.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118402: 24 FR 1.7 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118396: 24 FR 1.2 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118389: 18 FR 4.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118372: 18 FR 3.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118365: 18 FR 2.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118358: 18 FR 1.7 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071118341: 18 FR 1.2 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071113001: 24 FR 5.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112981: 24 FR 4.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112967: 24 FR 3.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112943: 24 FR 2.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112929: 24 FR 1.7 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112905: 24 FR 1.2 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112882: 18 FR 4.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112868: 18 FR 3.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112844: 18 FR 2.4 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112820: 18 FR 1.7 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112806: 18 FR 1.2 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112790: 28 FR 4.3 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112783: 28 FR 2.8 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071112776: 28 FR 1.5 cm AMT Non Balloon Button (Bard Equivalent) (Boxed)
• 00842071106591: 28 FR 4.3 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106584: 28 FR 2.8 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106577: 28 FR 1.5 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106553: 24 FR 5.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106539: 24 FR 4.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106515: 24 FR 3.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106492: 24 FR 2.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106478: 24 FR 1.7 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106454: 24 FR 1.2 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106430: 18 FR 4.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106416: 18 FR 3.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106393: 18 FR 2.4 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106379: 18 FR 1.7 cm AMT Non Balloon Button (Bard Equivalent)
• 00842071106355: 18 FR 1.2 cm AMT Non Balloon Button (Bard Equivalent)