Pylant Monitor

GUDID 00860010850909

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

Kal-Med, LLC

Artificial airway tube cuff pressure monitor
Primary Device ID00860010850909
NIH Device Record Key40ce7b5b-0b60-4d7c-a53d-950f0d193130
Commercial Distribution StatusIn Commercial Distribution
Brand NamePylant Monitor
Version Model NumberIM-1000
Company DUNS792118049
Company NameKal-Med, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net
Phone(585) 633-4225
EmailSupport@KalMed.net

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Clean & dry temperature controlled location out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100860010850909 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BSKCuff, Tracheal Tube, Inflatable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

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