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Ultipor™ Anesthesia Breathing Circuit System - Patient Kit

FDA UDI

Class II (US FDA UDI)

by Global Life Sciences Solutions USA LLC

Identity

Trade Name
Ultipor™ Anesthesia Breathing Circuit System - Patient Kit FDA UDI
Generic Name
Patient-end respiratory anaesthesia kit FDA UDI
Device Name
Extra-Large Vanilla-Scented Adult Face Mask, Ported Elbow, and Ultipor 25 Filter. Non-Conductive, Disposable. FDA UDI
Model / Reference
VMPKXL FDA UDI
Description
Extra-Large Vanilla-Scented Adult Face Mask, Ported Elbow, and Ultipor 25 Filter. Non-Conductive, Disposable. FDA UDI

Identifiers

Catalog Number
VMPKXL FDA UDI
Primary DI / UDI-DI
00636207315380 FDA UDI
510(k) Number
K013093 FDA UDI
FDA Product Code
CAH FDA UDI
GMDN Term
Patient-end respiratory anaesthesia kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5260 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Ultipor™ Anesthesia Breathing Circuit System - Patient Kit by Global Life Sciences Solutions USA LLC — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K013093 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Global Life Sciences Solutions USA LLC

Sources (1)

  • FDA UDI 8196a3c1-2b50-478e-b098-31830c95f0cf 38 fields · synced May 30, 2026