Decompression Tube E3-2412, 3-2412

GUDID 00842071131814

24F x 1.2 cm Decompression Tube (Pouched)

APPLIED MEDICAL TECHNOLOGY, INC.

Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube Gastrostomy tube

• Primary Device ID: 00842071131814
• NIH Device Record Key: 0004fcbf-5760-4912-a226-aa5ccf309e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Decompression Tube
• Version Model Number: E3-2412
• Catalog Number: E3-2412, 3-2412
• 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: false
• 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

Device Dimensions

• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter
• Catheter Gauge: 24 French
• Length: 1.2 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842071131487 [Primary]
GS1	00842071131814 [Package]; Contains: 00842071131487; Package: Box 10 (3-2412) [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980145

FDA Product Code

• KGC: Tube, Gastro-Enterostomy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-10
• Device Publish Date: 2023-06-30

On-Brand Devices [Decompression Tube]

• 00842071106348: 28F x 4.3 cm Decompression Tube (Pouched)
• 00842071106331: 28F x 2.8 cm Decompression Tube (Pouched)
• 00842071106324: 28F x 1.5 cm Decompression Tube (Pouched)
• 00842071106317: 24F x 4.4 cm Decompression Tube (Pouched)
• 00842071106300: 24F x 3.4 cm Decompression Tube (Pouched)
• 00842071106294: 24F x 2.4 cm Decompression Tube (Pouched)
• 00842071106287: 24F x 1.7 cm Decompression Tube (Pouched)
• 00842071106270: 24F x 1.2 cm Decompression Tube (Pouched)
• 00842071106263: 18F x 4.4 cm Decompression Tube (Pouched)
• 00842071106256: 18F x 3.4 cm Decompression Tube (Pouched)
• 00842071106249: 18F x 2.4 cm Decompression Tube (Pouched)
• 00842071106232: 18F x 1.7 cm Decompression Tube (Pouched)
• 00842071106225: 18F x 1.2 cm Decompression Tube (Pouched)
• 00842071131760: 18F x 1.2 cm Decompression Tube (Pouched)
• 00842071131852: 24F x 4.4 cm Decompression Tube (Pouched)
• 00842071131845: 24F x 3.4 cm Decompression Tube (Pouched)
• 00842071131838: 24F x 2.4 cm Decompression Tube (Pouched)
• 00842071131821: 24F x 1.7 cm Decompression Tube (Pouched)
• 00842071131814: 24F x 1.2 cm Decompression Tube (Pouched)
• 00842071131807: 18F x 4.4 cm Decompression Tube (Pouched)
• 00842071131463: 18F x 3.4 cm Decompression Tube (Pouched)
• 00842071131784: 18F x 2.4 cm Decompression Tube (Pouched)
• 00842071131777: 18F x 1.7 cm Decompression Tube (Pouched)