| Primary Device ID | 00884838014121 | 
| NIH Device Record Key | 1b1d8960-7e41-4155-ba51-f03299898d53 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Respironics | 
| Version Model Number | 6716-00 | 
| Catalog Number | 6716-00 | 
| Company DUNS | 093608594 | 
| Company Name | RESPIRONICS NOVAMETRIX, LLC | 
| Device Count | 1 | 
| DM Exempt | true | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00884838014121 [Primary] | 
| GS1 | 30884838014122 [Package] Package: [10 Units] In Commercial Distribution | 
| BXP | TRANSDUCER, GAS FLOW | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2020-09-22 | 
| Device Publish Date | 2020-09-14 | 
| 00884838059399 | Sample Line-Female Luer Connector | 
| 00884838056336 | CapnoTrak Dehumidification Tubing | 
| 00884838056329 | CapnoTrak Water Filter Assembly | 
| 00884838044531 | CapnoTrak O2 Delivery Extension Line | 
| 00884838044524 | CapnoTrak CO2 Sampling Extension Line | 
| 00884838044425 | CapnoTrak CO2/O2 Oral Nasal Cannula | 
| 00884838044418 | CapnoTrak CO2/O2 Oral Nasal Cannula | 
| 00884838044401 | CapnoTrak CO2 Oral Nasal Cannula | 
| 00884838044395 | CapnoTrak CO2 Oral Nasal Cannula | 
| 00884838040076 | CapnoTrak Airway Adapter Set | 
| 00884838040069 | CapnoTrak Airway Adapter Set | 
| 00884838040052 | CapnoTrak CO2/O2 Nasal Cannula | 
| 00884838040045 | CapnoTrak CO2/O2 Nasal Cannula | 
| 00884838040038 | CapnoTrak CO2/O2 Nasal Cannula | 
| 00884838040021 | CapnoTrak CO2 Nasal Cannula | 
| 00884838040014 | CapnoTrak CO2 Nasal Cannula | 
| 00884838040007 | CapnoTrak CO2 Nasal Cannula | 
| 00884838014411 | 15mm Male/Female Adapter-Low Deadspace | 
| 00884838014404 | 15mm Male/Female Adapter | 
| 00884838014381 | Sensor Cable Holding Clips | 
| 00884838014374 | CO2/Flow Sensor Adult | 
| 00884838014367 | CO2/Flow Sensor Pediatric | 
| 00884838014350 | CO2/Flow Sensor Neonatal | 
| 00884838014152 | Neonatal Flow Sensor Series 3 | 
| 00884838014145 | Pediatric/Adult Flow Sensor Series 3 | 
| 00884838014138 | Neonatal Combined CO2/Flow Sensor Series 3 | 
| 00884838014121 | Pediatric Combined CO2/Flow Sensor Series 3 | 
| 00884838014114 | Pediatric / Adult Combined CO2/Flow Sensor Series 3 | 
| 00884838014077 | Neonatal Airway Adapter | 
| 00884838014060 | Pediatric/Adult Airway Adapter | 
| 00884838014053 | Pediatric/Adult Airway Adapter with Mouthpiece | 
| 00884838014046 | Neonatal/Pediatric Airway Adapter | 
| 00884838014039 | Pediatric/Adult Airway Adapter | 
| 00884838014022 | LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL | 
| 00884838014015 | LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT ORAL/NASAL | 
| 00884838014008 | LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC ORAL/NASAL | 
| 00884838013995 | LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT ORAL/NASAL | 
| 00884838013988 | LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL | 
| 00884838013971 | LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing PEDIATRIC NASAL | 
| 00884838013964 | LoFlo CO2 Sampling O2 Delivery Cannula with Dehumidification Tubing ADULT NASAL | 
| 00884838013957 | LoFlo CO2 Sampling Cannula with Dehumidification Tubing INFANT/NEONATAL NASAL | 
| 00884838013940 | LoFlo CO2 Sampling Cannula with Dehumidification Tubing PEDIATRIC NASAL | 
| 00884838013933 | LoFlo CO2 Sampling Cannula with Dehumidification Tubing ADULT NASAL | 
| 00884838013926 | LoFlo SAMPLING LINE KIT w/Dehumidification Tubing | 
| 00884838013919 | LoFlo SAMPLING LINE KIT | 
| 00884838013902 | LoFlo Airway Adapter Kit w/Dehumidification Tubing INFANT/NEONATAL | 
| 00884838013896 | LoFlo Airway Adapter Kit w/ Dehumidification Tubing Adult/Pediatric | 
| 00884838013889 | LoFlo Airway Adapter Kit INFANT/NEONATAL | 
| 00884838013872 | LoFlo Airway Adapter Kit ADULT/PEDIATRIC | 
| 00884838013865 | LoFlo CO2 Sampling O2 Delivery Cannula PEDIATRIC ORAL/NASAL | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  RESPIRONICS  90374954  not registered Live/Pending | PHILIPS RS NORTH AMERICA LLC 2020-12-11 | 
|  RESPIRONICS  79299775  not registered Live/Pending | Koninklijke Philips N.V. 2020-11-04 |