Alaris 8120
GUDID 10885403494291
Alaris PCA Module
CAREFUSION 303, INC.
Patient-controlled analgesia infusion pump| Primary Device ID | 10885403494291 |
| NIH Device Record Key | 32035587-bff6-4a0f-ba06-7a9c1de129ec |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alaris |
| Version Model Number | 8120 |
| Catalog 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
Operating and Storage Conditions
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885403494291 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043299
FDA Product Code
| MEA | Pump, infusion, pca |
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 | 2021-10-07 |
| Device Publish Date | 2021-09-29 |
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 79398491 not registered Live/Pending |
TOHATSU CORPORATION 2024-04-16 |
 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 |
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