Mini ONE® Capsule Non-Balloon Button

GUDID 00842071101091

20FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button

APPLIED MEDICAL TECHNOLOGY, INC.

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• Primary Device ID: 00842071101091
• NIH Device Record Key: e32e2c8f-ee82-4f60-a0aa-aa5070319562
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mini ONE® Capsule Non-Balloon Button
• Version Model Number: M1-2-2034
• 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: 20 French
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French
• Length: 3.4 Centimeter
• Catheter Gauge: 20 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071101091 [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® Capsule Non-Balloon Button]

• 00842071118051: 24FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071118044: 24FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071118037: 24FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071118020: 24FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071118013: 20FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071118006: 20FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117993: 20FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117986: 20FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117979: 18FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117962: 18FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117955: 18FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117948: 18FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117931: 18FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117924: 18FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117917: 18FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117900: 18FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117894: 14FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117887: 14FR x 2.5 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117870: 14FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117863: 14FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117856: 14FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117849: 14FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071117832: 14FR x 1.0 cm Mini ONE® Capsule Non-Balloon Button (Enfit)
• 00842071101145: 24FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101138: 24FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101121: 24FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101114: 24FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101107: 20FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101091: 20FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101084: 20FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101077: 20FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101053: 18FR x 4.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101039: 18FR x 3.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071101015: 18FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100995: 18FR x 2.4 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100971: 18FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100957: 18FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100933: 18FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100919: 18FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100896: 14FR x 3.0 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100872: 14FR x 2.5 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100858: 14FR x 2.0 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100834: 14FR x 1.7 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100810: 14FR x 1.5 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100797: 14FR x 1.2 cm Mini ONE® Capsule Non-Balloon Button
• 00842071100773: 14FR x 1.0 cm Mini ONE® Capsule Non-Balloon Button