| Primary Device ID | 00855784004252 |
| NIH Device Record Key | f2cd9182-c8c2-452a-b641-4e23f72ef34f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiroFlow |
| Version Model Number | E5020 |
| Catalog Number | E5020-2-NOV |
| 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 | 00855784004252 [Primary] |
| 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 | 4 |
| Public Version Date | 2018-06-07 |
| 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 |