FDA.reportPublic FDA data

Pylant Monitor

Primary DI
00860010850909
Brand
Pylant Monitor
Company
Kal-Med, LLC
Model
IM-1000
Device description
Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered.
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSKCuff, Tracheal Tube, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSKCuff, Tracheal Tube, InflatableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191858000Pylant MonitorKal-Med, LLC2020-02-24BSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860010850909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860010850909008600108509098600108509090860010850909

GMDN Terms#

Term, Definition table
TermDefinition
Artificial airway tube cuff pressure monitorA mains electricity (AC-powered) device intended to intermittently or continuously measure the internal pressure in the cuff of an endotracheal (ET)/endobronchial/tracheostomy tube when this has been situated into the tracheal passage. Too high a cuff pressure and/or combined long periods of use can be damaging for the pressure site on the tracheal wall. It will provide and display a continuous monitoring of the situation which the anaesthetist can observe. Some types may also include the ability to inflate the cuff and regulate the pressure therein.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Clean & dry temperature controlled location out of sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(585) 633-4225Support@KalMed.net

Regulatory Flags#

DUNS number
792118049
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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03665023000993CuffGuardIDMEDBSK2025-12-19
03665023001020CuffGuardIDMEDBSK2025-12-19
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10889483002599SunMedSUNMED, LLCBSK2023-07-17
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyBSK2023-04-19
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