Primary Device ID | 00855784004030 |
NIH Device Record Key | e48c13de-94e5-40cc-b7a9-22db1357e023 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SpiroFlow |
Version Model Number | E5010 |
Catalog Number | E5010-2 |
Company DUNS | 830864406 |
Company Name | Spirometrics |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | 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 | true |
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 | 00855784004016 [Primary] |
GS1 | 00855784004023 [Package] Contains: 00855784004221 Package: box [2 Units] In Commercial Distribution |
GS1 | 00855784004030 [Package] Contains: 00855784004221 Package: box [8 Units] In Commercial Distribution |
GS1 | 00855784004221 [Package] Contains: 00855784004016 Package: box [12 Units] In Commercial Distribution |
BZH | Meter, Peak Flow, Spirometry |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-11 |
00855784004252 | Child Peak Flow Meter |
00855784004245 | Adult Peak Flow Meter |
00855784004054 | Child Peak Flow Meter |
00855784004030 | Adult Peak Flow Meter |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SPIROFLOW 87210218 5257889 Live/Registered |
Spiroflow Systems, Inc. 2016-10-20 |
SPIROFLOW 85437634 4146613 Live/Registered |
Spiroflow Systems, Inc. 2011-10-03 |
SPIROFLOW 75760632 2476462 Dead/Cancelled |
Mentor Corporation 1999-07-26 |
SPIROFLOW 74528887 not registered Dead/Abandoned |
Hilton Kapian and Anthony Edward Bunn Partnership, The 1994-05-24 |