Spirometrics

GUDID 00855784004160

Breathing mouthpiece, single-use

Primary Device ID	00855784004160
NIH Device Record Key	04f80ad1-492f-413c-8541-53d57c1093cb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Spirometrics
Version Model Number	D1030
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	00855784004153 [Package] Contains: 00855784004276 Package: bag [200 Units] In Commercial Distribution
GS1	00855784004160 [Package] Contains: 00855784004153 Package: box [3 Units] In Commercial Distribution
GS1	00855784004276 [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