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XVIVO Disposable Lung Kit

FDA UDI

Class III (US FDA UDI)

by Xvivo Perfusion, Inc.

Identity

Trade Name
XVIVO Disposable Lung Kit FDA UDI
Generic Name
Lung donor-organ preservation/evaluation system lung-interface set FDA UDI
Device Name
The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs. FDA UDI
Model / Reference
19046 FDA UDI
Description
The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs. FDA UDI

Identifiers

Catalog Number
19046 FDA UDI
Primary DI / UDI-DI
07350069520401 FDA UDI
PMA Number
P180014 FDA UDI
FDA Product Code
PHO FDA UDI
GMDN Term
Lung donor-organ preservation/evaluation system lung-interface set FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Lung donor-organ preservation/evaluation system lung-interface set

XVIVO Disposable Lung Kit by Xvivo Perfusion, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Lung donor-organ preservation/evaluation system lung-interface set.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Xvivo Perfusion, Inc.

Sources (1)

  • FDA UDI 1b91da75-7a9d-499a-8ec9-039308a69650 35 fields · synced Jun 20, 2026