Spirometrics

GUDID 00855784004146

Adult Mouthpiece, each

Spirometrics

Breathing mouthpiece, single-use
Primary Device ID00855784004146
NIH Device Record Key0a49aab2-03cb-4a79-8c2c-86c7739f641d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpirometrics
Version Model NumberD1020
Company DUNS830864406
Company NameSpirometrics
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com
Phone1-207-657-6700
Emailinfo@spirometrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100855784004092 [Package]
Contains: 00855784004283
Package: bag [200 Units]
In Commercial Distribution
GS100855784004108 [Package]
Contains: 00855784004092
Package: box [2 Units]
In Commercial Distribution
GS100855784004115 [Package]
Contains: 00855784004092
Package: box [5 Units]
In Commercial Distribution
GS100855784004122 [Package]
Contains: 00855784004283
Package: box [100 Units]
In Commercial Distribution
GS100855784004139 [Package]
Contains: 00855784004122
Package: box [4 Units]
In Commercial Distribution
GS100855784004146 [Package]
Contains: 00855784004122
Package: box [10 Units]
In Commercial Distribution
GS100855784004283 [Primary]

FDA Product Code

BYPMouthpiece, Breathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-23
Device Publish Date2017-04-03

On-Brand Devices [Spirometrics]

00855784004191Nose Clip, each
00855784004146Adult Mouthpiece, each
00855784004160Pediatric Mouthpiece, each
008557840042143 Liter Calibration Syringe, OEM
008557840042073 Liter Calibration Syringe, Spirometrics label

Trademark Results [Spirometrics]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SPIROMETRICS
SPIROMETRICS
75704596 2463259 Live/Registered
VUETEK SCIENTIFIC, LLC
1999-05-13
SPIROMETRICS
SPIROMETRICS
73521026 1388874 Dead/Cancelled
SPIROMETRICS, INC.
1985-02-06

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