9301 HAND CONTROLLER 112177

GUDID 00874750008131

PNEU HAND CNTRL SWITCH 9301

HANS RUDOLPH, INC.

Pulmonary function valve
Primary Device ID00874750008131
NIH Device Record Key45197e28-a905-4fa8-abb5-f4da67502284
Commercial Distribution StatusIn Commercial Distribution
Brand Name9301 HAND CONTROLLER
Version Model Number9301
Catalog Number112177
Company DUNS007131725
Company NameHANS RUDOLPH, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100874750008131 [Primary]

FDA Product Code

JAXPneumotachometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-03
Device Publish Date2018-11-02

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