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, 0.050" ID CO2 Gas Sampling Line and 1 Liter Non-Latex Breathing Bag. FDA UDI
Model / Reference: VM96PDLEX FDA UDI
Description: Pediatric 96" Expandable Dual Limb Circuit, 0.050" ID CO2 Gas Sampling Line and 1 Liter Non-Latex Breathing Bag. FDA UDI

Identifiers

Catalog Number: VM96PDLEX FDA UDI
Primary DI / UDI-DI: 00636207315342 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: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 96 Inch FDA UDI

Category: Anaesthesia breathing circuit, reusable

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

Similar devices

Also classified as Anaesthesia breathing circuit, reusable.

MATRX SCAV, W/SM HOOD(WO/SHUTOF — Parker Hannifin Corp. · Class I
AirTechniques — Baldus Sedation GmbH & Co. KG · Class I
Sil.Plus — Galemed Corp. · Class I
PORTER/BRN ADULT RG ASSY ONLY — Parker Hannifin Corp. · Class I
30MM UNIFLOW COAXIAL BREATHING SYSTEM WITH LUER ELBOW, AND LIMB, 2.4M — Intersurgical Incorporated · Class I
Trulink — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
Respiration Tubing — VBM Medizintechnik GmbH · Class I
MATRX SCAV, SHUTOFF VALVE(WO/HO — Parker Hannifin Corp. · Class I

Cleared under the same submission

K013093 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Global Life Sciences Solutions USA LLC

Sources (1)

FDA UDI 95e83ead-2d72-4616-8af1-8abd472cb3c0 37 fields · synced May 30, 2026