Flexichamber

GUDID 00323594901011

Holding Chambers, Direct Patient Interface

CERECOR INC.

Medicine chamber spacer, reusable
Primary Device ID00323594901011
NIH Device Record Key15306492-44c6-4e74-b95f-5ee433a931e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexichamber
Version Model NumberAnti-Static Valved Collapsible Holding Chamber
Company DUNS968799028
Company NameCERECOR INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100323594901011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVPHolding Chambers, Direct Patient Interface

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-06-26
Device Publish Date2018-10-01

On-Brand Devices [Flexichamber]

00323594901011Holding Chambers, Direct Patient Interface
00032359490201DEMO UNIT

Trademark Results [Flexichamber]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEXICHAMBER
FLEXICHAMBER
86239483 4827962 Live/Registered
FSC Laboratories, Inc.
2014-04-02

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