FOGG SYSTEM COMPANY, INC.

GUDID 00840416600278

0395-2291 Interface Cable

Fogg System Company, Inc.

Electrical-only medical device connection cable, reusable

• Primary Device ID: 00840416600278
• NIH Device Record Key: 577e1eab-cb33-4b36-b90a-14c33868638e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOGG SYSTEM COMPANY, INC.
• Version Model Number: 0395-2291
• Company DUNS: 058730946
• Company Name: Fogg System Company, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com
• Phone: +1(303)344-1883
• Email: compliance@foggsystem.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840416600278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222712

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2024-02-26
• Device Publish Date: 2024-02-16

On-Brand Devices [FOGG SYSTEM COMPANY, INC.]

• 00840416600520: 7390-0002
• 00840416600513: 0395-2555 Interface Cable
• 00840416600506: 0310-2203 Interface Cable
• 00840416600490: 0259-2455 Interface Cable
• 00840416600483: 0264-2535 Interface Cable
• 00840416600476: 0395-2584 Interface Cable
• 00840416600469: 0259-2517 Interface Cable
• 00840416600452: 0408-2535 Interface Cable
• 00840416600445: 0310-2248 Interface Cable
• 00840416600438: 0395-2534 Interface Cable
• 00840416600421: 0310-2254 Interface Cable
• 00840416600414: 0464-2455 Interface Cable
• 00840416600407: 0464-1083 Interface Cable
• 00840416600391: 0259-2417 Interface Cable
• 00840416600384: 0395-2494 Interface Cable
• 00840416600377: 0395-2535 Interface Cable
• 00840416600360: 0264-2454 Interface Cable
• 00840416600353: 0285-2474 Interface Cable
• 00840416600346: 0395-2197 Interface Cable
• 00840416600339: 0310-2256 Interface Cable
• 00840416600322: 0395-2454 Interface Cable
• 00840416600315: 0310-2351 Interface Cable
• 00840416600308: 0310-2524 Interface Cable
• 00840416600292: 0408-2361 Interface Cable
• 00840416600285: 0395-2049 Interface Cable
• 00840416600278: 0395-2291 Interface Cable
• 00840416600261: 0395-2555 Interface Cable
• 00840416600254: 0395-2531 Interface Cable
• 00840416600247: 0395-1969 Interface Cable
• 00840416600230: 0432-2474 Interface Cable
• 00840416600223: 0464-2526 Interface Cable
• 00840416600216: 0310-2588 Interface Cable
• 00840416600209: 0310-2454 Interface Cable
• 00840416600193: 0403-2351 Interface Cable
• 00840416600186: 0435-2306 Interface Cable
• 00840416600179: 0408-2454 Interface Cable
• 00840416600162: 0310-2474 Interface Cable
• 00840416600155: 0395-2515 Interface Cable
• 00840416600148: 0386-2469 Interface Cable
• 00840416600131: 0408-2474 Interface Cable
• 00840416600124: 0386-2474 Interface Cable
• 00840416600117: 0285-2517 Interface Cable
• 00840416600100: 0464-2054 Interface Cable
• 00840416600094: 0467-2455 Interface Cable
• 00840416600087: 0386-2417 Interface Cable
• 00840416600070: 0395-2454-2454 Adapter Cable
• 00840416600063: 0310-2411 Interface Cable
• 00840416600056: 0310-2252 Interface Cable
• 00840416600049: 0408-2584 Interface Cable
• 00840416600032: 0259-2474 Interface Cable