Nellcor
GUDID 20884521705347
GE CARESCAPE SpO2 - Nellcor. For use with GE Patient Monitors.
Covidien LP
Patient monitoring system module, pulse oximetry| Primary Device ID | 20884521705347 |
| NIH Device Record Key | 7cddd949-7716-467b-a5a6-c554d902fb0c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nellcor |
| Version Model Number | PMC10GE360N |
| Company DUNS | 058614483 |
| Company Name | Covidien LP |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
| Length | 3.6 Meter |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 108 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10884521705340 [Primary] |
| GS1 | 20884521705347 [Package] Contains: 10884521705340 Package: CASE [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K172482
FDA Product Code
| DQA | Oximeter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-09-15 |
| Device Publish Date | 2018-03-22 |
On-Brand Devices [Nellcor]
| 30884522043667 | Adult-Neonatal Adhesive Sensor Wrap |
| 30884522000813 | Pediatric SpO2 Sensor |
| 10884522042710 | Adult SpO2 Sensor,Reusable |
| 20884522001141 | Neonatal-Adult SpO2 Sensor |
| 20884522000908 | Infant SpO2 Sensor |
| 20884522000854 | Adult XL SpO2 Sensor |
| 20884522000847 | Adult SpO2 Sensor |
| 10884521080553 | Headband RS10 Sensor |
| 10884522043038 | Sensor Extension Cable,Unterminated,Caution: For manufacturing, processing, or repacking |
| 10884522042826 | Pediatric-Infant SpO2 Sensor with Wraps |
| 10884522042789 | Pulse Oximetry Interface Cable,Unterminated,Caution: For manufacturing, processing or repacking. |
| 10884522042680 | Pediatric SpO2 Sensor Clip,Reusable |
| 10884522042659 | Sensor Cable |
| 10884522042611 | Neonatal SpO2 Sensor,Non-Adhesive |
| 10884522042543 | SpO2 Sensor,Multisite Reusable |
| 30884522042530 | Pediatric-Infant Adhesive Sensor Wrap |
| 10884522042451 | Adult SpO2 Sensor,Non-Adhesive |
| 10884522042437 | Neonatal SpO2 Sensor,Non-Adhesive |
| 10884522042420 | Pulse Oximetry Interface Cable |
| 10884522042314 | Pediatric SpO2 Sensor |
| 10884522042307 | Pediatric SpO2 Sensor |
| 10884522042291 | Pediatric SpO2 Sensor |
| 10884522042284 | Pediatric SpO2 Sensor |
| 10884522042277 | Pediatric SpO2 Sensor,Remanufactured |
| 10884522042260 | Adult XL SpO2 Sensor |
| 10884522042185 | Adult XL SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien l |
| 10884522042178 | Pediatric SpO2 Sensor,Two Piece |
| 10884522042161 | Neonatal-Adult SpO2 Sensor,Two Piece |
| 10884522042154 | Neonatal-Adult SpO2 Sensor,Two Piece |
| 10884522042147 | Pediatric SpO2 Sensor,Two Piece |
| 10884522042130 | Adult SpO2 Sensor,Two Piece |
| 10884522042123 | Adult SpO2 Sensor Two Piece |
| 10884522042116 | Infant SpO2 Sensor,Two Piece |
| 10884522041720 | Neonatal-Adult SpO2 Sensor |
| 10884522041713 | Neonatal-Adult SpO2 Sensor |
| 10884522041287 | Infant SpO2 Sensor |
| 10884522041270 | Infant SpO2 Sensor |
| 10884522040945 | Infant SpO2 Sensor |
| 10884522040891 | Infant SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc |
| 10884522040884 | Infant SpO2 Sensor |
| 10884522040389 | Adult SpO2 Nasal Sensor |
| 10884522040372 | Neonatal-Adult SpO2 Sensor |
| 10884522040310 | Adult SpO2 Nasal Sensor |
| 10884522040303 | Adult SpO2 Nasal Sensor |
| 10884522040105 | Adult SpO2 Sensor,Remanufactured,Reprocessed device for single use; Reprocessed by Covidien llc |
| 10884522040099 | Adult SpO2 Sensor |
| 10884522040082 | Adult SpO2 Sensor |
| 10884522040075 | Adult SpO2 Sensor |
| 10884522039697 | Forehead SpO2 Sensor |
| 10884521617476 | Flexible SpO2 Reusable Sensor, Homecare, Small |
Trademark Results [Nellcor]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NELLCOR 75094032 2129840 Live/Registered |
COVIDIEN LP 1996-04-25 |
 NELLCOR 73731594 1532876 Dead/Cancelled |
NELLCOR INCORPORATED 1988-05-31 |
 NELLCOR 73429077 1301428 Live/Registered |
Nellcor, Inc. 1983-06-06 |
 NELLCOR 73385330 1276853 Live/Registered |
Nellcor Incorporated 1982-09-13 |
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