| 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 |