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Spiration Valve System

FDA UDI

Class III (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
Spiration Valve System FDA UDI
Generic Name
Endobronchial valve delivery catheter FDA UDI
Device Name
Deployment Catheter and Loader, 2.6 FDA UDI
Model / Reference
SVS-C26N-06 FDA UDI
Description
Deployment Catheter and Loader, 2.6 FDA UDI

Identifiers

Primary DI / UDI-DI
00896506002316 FDA UDI
PMA Number
P180007 FDA UDI
FDA Product Code
NJK FDA UDI
GMDN Term
Endobronchial valve delivery catheter 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: Endobronchial valve delivery catheter

Spiration Valve System by Gyrus Acmi, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endobronchial valve delivery catheter.

Cleared under the same submission

P180007 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI c918011e-33b1-439f-950c-c052d152e47d 34 fields · synced May 30, 2026