| Primary Device ID | 00855784004245 | 
| NIH Device Record Key | ae0e040a-10b7-4b40-885f-65ec6c8a7d96 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SpiroFlow | 
| Version Model Number | E5010 | 
| Catalog Number | E5010-2-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 | 00855784004245 [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 | 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 |