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Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit

FDA UDI

Class II (US FDA UDI)

by Global Life Sciences Solutions USA LLC

Identity

Trade Name
Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine Kit FDA UDI
Generic Name
Anaesthesia breathing circuit, reusable FDA UDI
Device Name
Pediatric 96" Expandable Dual Limb Circuit and 1 Liter Non-Latex Breathing Bag. FDA UDI
Model / Reference
VM96PDLEXNC FDA UDI
Description
Pediatric 96" Expandable Dual Limb Circuit and 1 Liter Non-Latex Breathing Bag. FDA UDI

Identifiers

Catalog Number
VM96PDLEXNC FDA UDI
Primary DI / UDI-DI
00636207315359 FDA UDI
510(k) Number
K013093 FDA UDI
FDA Product Code
CAH FDA UDI
GMDN Term
Anaesthesia breathing circuit, reusable 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

Dimensions & Sizes

Size
Length — 96 Inch FDA UDI

Ultipor™ Anesthesia Breathing Circuit System - Pediatric Machine 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 c0bf18a5-d24b-43dd-b3b8-3683bd5957eb 38 fields · synced Jun 8, 2026