Spirometrics

GUDID 00855784004146

Breathing mouthpiece, single-use

Primary Device ID	00855784004146
NIH Device Record Key	0a49aab2-03cb-4a79-8c2c-86c7739f641d
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spirometrics
Version Model Number	D1020
Company DUNS	830864406
Company Name	Spirometrics
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00855784004092 [Package] Contains: 00855784004283 Package: bag [200 Units] In Commercial Distribution
GS1	00855784004108 [Package] Contains: 00855784004092 Package: box [2 Units] In Commercial Distribution
GS1	00855784004115 [Package] Contains: 00855784004092 Package: box [5 Units] In Commercial Distribution
GS1	00855784004122 [Package] Contains: 00855784004283 Package: box [100 Units] In Commercial Distribution
GS1	00855784004139 [Package] Contains: 00855784004122 Package: box [4 Units] In Commercial Distribution
GS1	00855784004146 [Package] Contains: 00855784004122 Package: box [10 Units] In Commercial Distribution
GS1	00855784004283 [Primary]

BYP	Mouthpiece, Breathing

Steralize Prior To Use	false
Device Is Sterile	false

00855784004191	Nose Clip, each
00855784004146	Adult Mouthpiece, each
00855784004160	Pediatric Mouthpiece, each
00855784004214	3 Liter Calibration Syringe, OEM
00855784004207	3 Liter Calibration Syringe, Spirometrics label

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