| Primary Device ID | 30884838105615 |
| NIH Device Record Key | 803079cc-b675-49b4-bcbc-819f120c36ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Respironics |
| Version Model Number | 1149948 |
| Catalog Number | 1149948 |
| Company DUNS | 093608594 |
| Company Name | Respironics Novametrix, LLC |
| Device Count | 10 |
| 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 |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com | |
| Phone | +1(724)744-2500 |
| Respironics.Service@philips.com |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884838105614 [Unit of Use] |
| GS1 | 30884838105615 [Primary] |
| BZA | CONNECTOR, AIRWAY (EXTENSION) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-23 |
| Device Publish Date | 2023-11-15 |
| 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 |