MiniONE Non-Balloon Button M1-1-1844

GUDID 00842071143589

18FR x 4.4 cm MiniONE Non-Balloon Button, MDR

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy button

• Primary Device ID: 00842071143589
• NIH Device Record Key: 1a15bb66-1ea8-4e31-baf7-dba2ede23295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiniONE Non-Balloon Button
• Version Model Number: M1-1-1844
• Catalog Number: M1-1-1844
• 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: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter
• Catheter Gauge: 18 French
• Length: 4.4 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071143589 [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

On-Brand Devices [MiniONE Non-Balloon Button]

• 00842071143756: 24FR x 4.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143749: 24FR x 4.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143732: 24FR x 3.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143725: 24FR x 3.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143718: 24FR x 2.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143701: 24FR x 2.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143695: 24FR x 1.7 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143688: 24FR x 1.7 cm MiniONE Non-Balloon Button, MDR
• 00842071143671: 20FR x 4.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143664: 20FR x 4.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143657: 20FR x 3.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143640: 20FR x 3.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143633: 20FR x 2.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143626: 20FR x 2.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143619: 20FR x 1.7 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143602: 20FR x 1.7 cm MiniONE Non-Balloon Button, MDR
• 00842071143596: 18FR x 4.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143589: 18FR x 4.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143572: 18FR x 3.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143565: 18FR x 3.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143558: 18FR x 3.0 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143541: 18FR x 3.0 cm MiniONE Non-Balloon Button, MDR
• 00842071143534: 18FR x 2.4 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143527: 18FR x 2.4 cm MiniONE Non-Balloon Button, MDR
• 00842071143510: 18FR x 2.0 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143503: 18FR x 2.0 cm MiniONE Non-Balloon Button, MDR
• 00842071143497: 18FR x 1.7 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143480: 18FR x 1.7 cm MiniONE Non-Balloon Button, MDR
• 00842071143473: 18FR x 1.5 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143466: 18FR x 1.5 cm MiniONE Non-Balloon Button, MDR
• 00842071143459: 18FR x 1.2 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143442: 18FR x 1.2 cm MiniONE Non-Balloon Button, MDR
• 00842071143435: 14FR x 3.0 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143428: 14FR x 3.0 cm MiniONE Non-Balloon Button, MDR
• 00842071143411: 14FR x 2.5 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143404: 14FR x 2.5 cm MiniONE Non-Balloon Button, MDR
• 00842071143398: 14FR x 2.0 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143381: 14FR x 2.0 cm MiniONE Non-Balloon Button, MDR
• 00842071143374: 14FR x 1.7 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143367: 14FR x 1.7 cm MiniONE Non-Balloon Button, MDR
• 00842071143350: 14FR x 1.5 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143343: 14FR x 1.5 cm MiniONE Non-Balloon Button, MDR
• 00842071143336: 14FR x 1.2 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143329: 14FR x 1.2 cm MiniONE Non-Balloon Button, MDR
• 00842071143312: 14FR x 1.0 cm MiniONE Non-Balloon Button (ENFit), MDR
• 00842071143305: 14FR x 1.0 cm MiniONE Non-Balloon Button, MDR