Spiration Valve System

GUDID 00896506002200

Valve in Cartridge, 9mm

Gyrus Acmi, Inc.

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Primary Device ID00896506002200
NIH Device Record Key2f51a71e-b4d8-4cb4-a9ab-90d588b8cb2f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiration Valve System
Version Model NumberHUS-V9
Company DUNS117521967
Company NameGyrus Acmi, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter
Outer Diameter9 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100896506002200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OAZOne-Way Air-Leak Valve

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-03-04
Device Publish Date2016-09-24

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