Cosmed Bod Pod Tube and Filter Kit - US & Canada 180014

GUDID 00817081022582

Kit, ViroMax, 24" Tubing, For Cosmed Bod Pod - US and Canada

A-M SYSTEMS, LLC

Pulmonary function testing kit

• Primary Device ID: 00817081022582
• NIH Device Record Key: 3fbf1a31-eced-4d0b-aa1a-d71d222ab694
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cosmed Bod Pod Tube and Filter Kit - US & Canada
• Version Model Number: Bod Pod Tube and Filter Kit - US & Canada - 180014
• Catalog Number: 180014
• Company DUNS: 020275145
• Company Name: A-M SYSTEMS, LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• 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: 3606838300
• Email: sales@a-msystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817081022575 [Primary]
GS1	00817081022582 [Package]; Contains: 00817081022575; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063526

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2019-09-20
• Device Publish Date: 2019-09-12

Devices Manufactured by A-M SYSTEMS, LLC

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• 00817081027976 - VBMax30E, PF Testing Filter: 2025-02-04 VBMax30E, Pulmonary Function Testing Filter, Labeled DR Burton
• 00817081027990 - VBMax30, PF Testing Filter: 2025-02-04 VBMax30, Pulmonary Function Testing Filter, Labeled DR Burton
• 00817081028010 - VBMax34S, PF Testing Filter Labeled DR Burton: 2025-02-04 VBMax34S, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081028034 - VBMax34E, PF Testing Filter Labeled DR Burton: 2025-02-04 VBMax34E, Pulmonary Function Testing Filter Labeled DR Burton
• 00817081027914 - 3 Liter Aluminum Calibration Syringe w/ Adapter: 2024-11-15 3 Liter Aluminum Calibration Syringe w/ Adapter
• 00817081027884 - PFT Kit A, 28MM O.D: 2024-11-01 Pulmonary Function Test Kit A, 28MM O.D., W/Foam Nose Clip & Rubber Mouthpiece
• 00817081027907 - PFT Kit J, VBMax36S: 2024-11-01 Pulmonary Function Test Kit J, VBMax36S with Blue Foam Nose Clip