Alaris
GUDID 10885403812033
Alaris PCA Module
CAREFUSION 303, INC.
Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Patient-controlled analgesia infusion pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump Bedside syringe pump| Primary Device ID | 10885403812033 |
| NIH Device Record Key | cc56efc8-6ebf-4a02-97cc-4b7a6a0f80df |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alaris |
| Version Model Number | 8120 |
| Company DUNS | 360624720 |
| Company Name | CAREFUSION 303, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com | |
| Phone | +1(888)237-2762 |
| ProductComplaints@bd.com |
Operating and Storage Conditions
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885403812033 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072105
FDA Product Code
| FRN | Pump, infusion |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-10-18 |
| Device Publish Date | 2021-10-08 |
On-Brand Devices [Alaris]
| 50885403463967 | GEM V/NV 20D 0.2 Fltr |
| 50885403463950 | GEM V/NV 20D No Port |
| 50885403460232 | PCEA ASV YELLOW MICROBORE |
| 50885403422315 | Alaris Pump Module Low Sorbing Infusion Set |
| 50885403283961 | Alaris Pump Module Infusion Set |
| 50885403275249 | Alaris SE Pump Infusion Set |
| 50885403274198 | Alaris Gravity Blood Set |
| 50885403274105 | Alaris Pump Module Enteral Set |
| 50885403274075 | Alaris Pump Module Burette Infusion Set |
| 50885403274068 | Alaris Pump Module Infusion Set |
| 50885403274051 | Alaris Pump Module Infusion Set |
| 50885403274037 | Alaris Pump Module Infusion Set |
| 50885403274006 | PCA Administration Set |
| 50885403273993 | Alaris PCA Administration Set |
| 50885403273979 | Alaris Extension Set |
| 50885403273962 | Alaris PCEA Administration Set |
| 50885403273955 | Alaris PCA Administration Set |
| 50885403273948 | Alaris PCA Administration Set |
| 50885403273863 | Alaris Gravity Set |
| 50885403273856 | SEC SET 200 MF BLOOD D/C NV SPK CONN |
| 50885403238619 | Alaris Gravity Set |
| 50885403235731 | Alaris Secondary Set |
| 50885403235717 | Alaris Gravity Set |
| 50885403235656 | Alaris Gravity Set |
| 50885403235649 | Alaris Extension Set |
| 50885403235618 | Alaris Extension Set |
| 50885403235601 | Alaris Extension Set |
| 50885403235540 | Alaris Pump Module Infusion Half Set |
| 50885403235519 | Alaris Extension Set |
| 50885403235502 | Alaris Extension Set |
| 50885403235496 | Alaris Extension Set |
| 50885403235489 | Alaris Low Sorbing Extension Set |
| 50885403235465 | Alaris Secondary Set |
| 50885403235229 | Alaris Extension Set |
| 50885403235137 | Alaris 3 Port Manifold |
| 50885403235052 | Alaris Pump Module Burette Set |
| 50885403234901 | Alaris Extension Set |
| 50885403234796 | Alaris Gravity Set |
| 50885403234758 | Alaris Secondary Set |
| 50885403234741 | Alaris Secondary Set |
| 50885403234666 | Alaris Extension Set |
| 50885403234604 | Alaris Syringe Module Syringe Administration Set |
| 50885403234598 | Alaris Extension Set |
| 50885403234543 | Alaris Gravity Blood Set |
| 50885403234536 | Alaris Extension Set |
| 50885403234420 | Alaris PCEA Administration Set |
| 50885403234413 | Alaris PCA Administration Kit |
| 50885403234406 | Alaris PCA Administration Kit |
| 50885403234390 | Alaris PCA Administration Kit |
| 50885403234383 | Alaris PCA Administration Kit |
Trademark Results [Alaris]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALARIS 88647609 not registered Live/Pending |
Grupo Penaflor S.A. 2019-10-09 |
 ALARIS 87514737 not registered Live/Pending |
Alaris LLC 2017-07-03 |
 ALARIS 86708679 5034557 Live/Registered |
Alaris Aerospace Systems LLC 2015-07-29 |
 ALARIS 86053118 5570809 Live/Registered |
111616 Opco (Delaware) Inc. 2013-08-30 |
 ALARIS 78945352 4084511 Dead/Cancelled |
The Alaris Group, Inc. 2006-08-04 |
 ALARIS 78633042 not registered Dead/Abandoned |
HNI Technologies Inc. 2005-05-19 |
 ALARIS 78396347 not registered Dead/Abandoned |
HNI TECHNOLOGIES INC. 2004-04-05 |
 ALARIS 78082482 not registered Dead/Abandoned |
Carrafiello Diehl & Associates, Inc. 2001-09-04 |
 ALARIS 77327656 not registered Dead/Abandoned |
Advance Polybag, Inc. 2007-11-12 |
 ALARIS 76536655 2930177 Live/Registered |
THE ALARIS GROUP, INC. 2003-07-03 |
 ALARIS 76411628 2693068 Dead/Cancelled |
Alaris, Inc. 2002-05-23 |
 ALARIS 76411625 2695504 Dead/Cancelled |
Alaris, Inc. 2002-05-23 |
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