Spirometrics
GUDID 00855784004146
Adult Mouthpiece, each
Spirometrics
Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use Breathing mouthpiece, single-use| Primary Device ID | 00855784004146 |
| NIH Device Record Key | 0a49aab2-03cb-4a79-8c2c-86c7739f641d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spirometrics |
| Version Model Number | D1020 |
| 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 | true |
| 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 | false |
Customer Support Contacts
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com | |
| Phone | 1-207-657-6700 |
| info@spirometrics.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00855784004092 [Package] Contains: 00855784004283 Package: bag [200 Units] In Commercial Distribution |
| GS1 | 00855784004108 [Package] Contains: 00855784004092 Package: box [2 Units] In Commercial Distribution |
| GS1 | 00855784004115 [Package] Contains: 00855784004092 Package: box [5 Units] In Commercial Distribution |
| GS1 | 00855784004122 [Package] Contains: 00855784004283 Package: box [100 Units] In Commercial Distribution |
| GS1 | 00855784004139 [Package] Contains: 00855784004122 Package: box [4 Units] In Commercial Distribution |
| GS1 | 00855784004146 [Package] Contains: 00855784004122 Package: box [10 Units] In Commercial Distribution |
| GS1 | 00855784004283 [Primary] |
FDA Product Code
| BYP | Mouthpiece, Breathing |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2017-04-03 |
On-Brand Devices [Spirometrics]
| 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 |
Trademark Results [Spirometrics]
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 |
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