MiniONE Non-Balloon Button M1-1-1820

GUDID 00842071143503

18FR x 2.0 cm MiniONE Non-Balloon Button, MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071143503
• NIH Device Record Key: 0e51762f-1118-4165-891b-08f779d84c03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniONE Non-Balloon Button
• Version Model Number: M1-1-1820
• Catalog Number: M1-1-1820
• 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: 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 Dimensions

• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter
• Catheter Gauge: 18 French
• Length: 2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071143503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170319

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: 2024-09-23
• Device Publish Date: 2024-09-13

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• 00842071143466: 18FR x 1.5 cm MiniONE Non-Balloon Button, MDR
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