Spiration Valve System

GUDID 00896506002286

Valve in Cartridge , 5mm

SPIRATION, INC.

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Primary Device ID00896506002286
NIH Device Record Keyc68e5786-a3d6-4563-b2bb-b5e8eb241d4e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiration Valve System
Version Model NumberSVS-V5-00
Company DUNS003664419
Company NameSPIRATION, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100896506002286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJKValve, Pulmonary

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-08
Device Publish Date2019-03-29

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00896506002293Valve in Cartridge, 6mm
00896506002286Valve in Cartridge , 5mm
00896506002279Valve in Cartridge, 7mm

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