Mini ONE® Non-Balloon Button

GUDID 00842071101176

14FR x 1.5 cm Mini ONE® Non-Balloon Button

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071101176
• NIH Device Record Key: 100eb0c4-cb5f-4088-93b0-362af32fd6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini ONE® Non-Balloon Button
• Version Model Number: M1-1-1415
• Company DUNS: 038101861
• Company Name: APPLIED MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• Phone: (440)717-4000
• Email: cs@appliedmedical.net

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French
• Length: 1.5 Centimeter
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071101176 [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: 5
• Public Version Date: 2019-10-07
• Device Publish Date: 2016-08-31

On-Brand Devices [Mini ONE® Non-Balloon Button]

• 00842071117825: 24FR x 4.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117818: 24FR x 3.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117801: 24FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117795: 24FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117788: 20FR x 4.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117771: 20FR x 3.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117764: 20FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117757: 20FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117740: 18FR x 4.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117733: 18FR x 3.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117726: 18FR x 3.0 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117719: 18FR x 2.4 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117702: 18FR x 2.0 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117696: 18FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117689: 18FR x 1.5 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117672: 18FR x 1.2 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117665: 14FR x 3.0 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117658: 14FR x 2.5 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117641: 14FR x 2.0 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117634: 14FR x 1.7 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117627: 14FR x 1.5 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117610: 14FR x 1.2 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071117603: 14FR x 1.0 cm Mini ONE® Non-Balloon Button (Enfit)
• 00842071101374: 24FR x 4.4 cm Mini ONE® Non-Balloon Button
• 00842071101367: 24FR x 3.4 cm Mini ONE® Non-Balloon Button
• 00842071101350: 24FR x 2.4 cm Mini ONE® Non-Balloon Button
• 00842071101343: 24FR x 1.7 cm Mini ONE® Non-Balloon Button
• 00842071101336: 20FR x 4.4 cm Mini ONE® Non-Balloon Button
• 00842071101329: 20FR x 3.4 cm Mini ONE® Non-Balloon Button
• 00842071101312: 20FR x 2.4 cm Mini ONE® Non-Balloon Button
• 00842071101305: 20FR x 1.7 cm Mini ONE® Non-Balloon Button
• 00842071101299: 18FR x 4.4 cm Mini ONE® Non-Balloon Button
• 00842071101282: 18FR x 3.4 cm Mini ONE® Non-Balloon Button
• 00842071101275: 18FR x 3.0 cm Mini ONE® Non-Balloon Button
• 00842071101268: 18FR x 2.4 cm Mini ONE® Non-Balloon Button
• 00842071101251: 18FR x 2.0 cm Mini ONE® Non-Balloon Button
• 00842071101244: 18FR x 1.7 cm Mini ONE® Non-Balloon Button
• 00842071101237: 18FR x 1.5 cm Mini ONE® Non-Balloon Button
• 00842071101220: 18FR x 1.2 cm Mini ONE® Non-Balloon Button
• 00842071101213: 14FR x 3.0 cm Mini ONE® Non-Balloon Button
• 00842071101206: 14FR x 2.5 cm Mini ONE® Non-Balloon Button
• 00842071101190: 14FR x 2.0 cm Mini ONE® Non-Balloon Button
• 00842071101183: 14FR x 1.7 cm Mini ONE® Non-Balloon Button
• 00842071101176: 14FR x 1.5 cm Mini ONE® Non-Balloon Button
• 00842071101169: 14FR x 1.2 cm Mini ONE® Non-Balloon Button
• 00842071101152: 14FR x 1.0 cm Mini ONE® Non-Balloon Button