Spiration Valve System - Valve in Cartridge, 9mm - Gyrus Acmi, Inc.

Duns Number:117521967

Device Description: Valve in Cartridge, 9mm

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More Product Details

Catalog Number

-

Brand Name

Spiration Valve System

Version/Model Number

HUS-V9

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

H060002

Product Code Details

Product Code

OAZ

Product Code Name

One-Way Air-Leak Valve

Device Record Status

Public Device Record Key

2f51a71e-b4d8-4cb4-a9ab-90d588b8cb2f

Public Version Date

March 04, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GYRUS ACMI, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 899
2 A medical device with a moderate to high risk that requires special controls. 1586
3 A medical device with high risk that requires premarket approval 9
U Unclassified 4