SpiroFlow E5020-2

GUDID 00855784004054

Child Peak Flow Meter

Spirometrics

Peak flow meter, manual
Primary Device ID00855784004054
NIH Device Record Keyb61be997-e0a4-48fd-b3e5-7bdf5d066c18
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpiroFlow
Version Model NumberE5020
Catalog NumberE5020-2
Company DUNS830864406
Company NameSpirometrics
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com
Phone207-657-6700
Emailinfo@spirometrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855784004047 [Primary]
GS100855784004054 [Package]
Contains: 00855784004238
Package: box [2 Units]
In Commercial Distribution
GS100855784004061 [Package]
Contains: 00855784004238
Package: box [8 Units]
In Commercial Distribution
GS100855784004238 [Package]
Contains: 00855784004047
Package: box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZHMeter, Peak Flow, Spirometry

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-11

On-Brand Devices [SpiroFlow]

00855784004252Child Peak Flow Meter
00855784004245Adult Peak Flow Meter
00855784004054Child Peak Flow Meter
00855784004030Adult Peak Flow Meter

Trademark Results [SpiroFlow]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIROFLOW
SPIROFLOW
87210218 5257889 Live/Registered
Spiroflow Systems, Inc.
2016-10-20
SPIROFLOW
SPIROFLOW
85437634 4146613 Live/Registered
Spiroflow Systems, Inc.
2011-10-03
SPIROFLOW
SPIROFLOW
75760632 2476462 Dead/Cancelled
Mentor Corporation
1999-07-26
SPIROFLOW
SPIROFLOW
74528887 not registered Dead/Abandoned
Hilton Kapian and Anthony Edward Bunn Partnership, The
1994-05-24

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