Pylant Monitor

GUDID 00860010850909

Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered.

Kal-Med, LLC

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• Primary Device ID: 00860010850909
• NIH Device Record Key: 40ce7b5b-0b60-4d7c-a53d-950f0d193130
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pylant Monitor
• Version Model Number: IM-1000
• Company DUNS: 792118049
• Company Name: Kal-Med, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net
• Phone: (585) 633-4225
• Email: Support@KalMed.net

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Clean & dry temperature controlled location out of sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010850909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191858

FDA Product Code

• BSK: Cuff, Tracheal Tube, Inflatable

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: 2023-09-11
• Device Publish Date: 2023-09-01