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Pylant Monitor

FDA UDI

Class II (US FDA UDI)

by Kal-Med, Llc.

Identity

Trade Name
Pylant Monitor FDA UDI
Generic Name
Artificial airway tube cuff pressure monitor FDA UDI
Device Name
Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered. FDA UDI
Model / Reference
IM-1000 FDA UDI
Description
Pylant Monitor - Disposable endotracheal tube cuff pressure monitor (15 units per box) - non AC-powered. FDA UDI

Identifiers

Primary DI / UDI-DI
00860010850909 FDA UDI
510(k) Number
K191858 FDA UDI
FDA Product Code
BSK FDA UDI
GMDN Term
Artificial airway tube cuff pressure monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Artificial airway tube cuff pressure monitor

Pylant Monitor by Kal-Med, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Artificial airway tube cuff pressure monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kal-Med, Llc.

Sources (1)

  • FDA UDI 40ce7b5b-0b60-4d7c-a53d-950f0d193130 36 fields · synced May 30, 2026