Primary Device ID | 00855784004207 |
NIH Device Record Key | 6837a2ad-3c54-401d-8769-4d7358a04863 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spirometrics |
Version Model Number | N4010 |
Catalog Number | N4010-2 |
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 | false |
Lot Batch | false |
Serial Number | true |
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 |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com | |
Phone | 207-657-6700 |
info@spirometrics.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00855784004207 [Primary] |
BXW | Calibrator, Volume, Gas |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-04-03 |
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 |