FDA.reportPublic FDA data

Alaris

Primary DI
50885403274105
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
2205-0000
Catalog number
2205-0000
Device description
Alaris Pump Module Enteral Set
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZHPUMP, INFUSION, ENTERAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZHPump, Infusion, EnteralGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K946168000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K946168000IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPSIvac Corporation1996-03-21LZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403274105PrimaryGS10
10885403274107Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540327410550885403274105
1088540327410710885403274107

GMDN Terms#

Term, Definition table
TermDefinition
Enteral feeding kit, adult/paediatric, non-sterileA collection of non-sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an adult or paediatric (excludes infants) patient by means of gravity or an enteral pump. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7128CustCareInfusion@carefusion.com

Regulatory Flags#

DUNS number
360624720
Device count
20
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403477829Pyxis3383382018-10-15
10885403533228BD Pyxis3233232025-11-14
10885403533235BD Pyxis3243242025-11-14
10885403533242Pyxis3273272025-11-14
10885403521836Pyxis Pro MedStation177-216177-2162025-08-01
10885403521966Pyxis Pro MedStationSW-MS-ES-PRO-V48SW-MS-ES-PRO-V482025-08-01
10885403521935Pyxis MedStationSW-MS-ES-V48SW-MS-ES-V482025-07-23
10885403517822Pyxis Pro MedStation1149-001149-002025-06-05
10885403517839Pyxis Pro MedStation1152-001152-002025-06-05
10885403521300Pyxis Pro MedStation1155-001155-002025-06-05
10885403518348BD Pyxis™SW-SVR-ES-551115-002024-12-06
10885403520327BD Pyxis™SW-MS-ES-V47SW-MS-ES-V472024-12-06
10885403520341BD Pyxis™SW-SVR-ES-57SW-SVR-ES-572024-12-06
10885403517167BD Pyxis1145-001145-002023-09-29
10885403517174BD Pyxis1146-001146-002023-09-29
10885403517181BD Pyxis1147-001147-002023-09-29
10885403517198BD Pyxis1148-001148-002023-09-29
10885403513749BD PyxisSW-MS-4000-V7SW-MS-4000-V72022-12-02
10885403513756BD PyxisSW-MS-ES-V4SW-MS-ES-V42022-12-02
10885403513770BD PyxisSW-PAS-ES-V2SW-PAS-ES-V22022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253009675KangarooCardinal Health 200, LLCLZH2026-05-12
10885380193071KangarooCardinal Health 200, LLCLZH2026-03-16
50885380193079KangarooCardinal Health 200, LLCLZH2026-03-16
10192253068900KangarooCardinal Health 200, LLCLZH2025-09-30
10192253068917KangarooCardinal Health 200, LLCLZH2025-09-30
00197886002300Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008203Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00197886008210Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886002304Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
20197886008207Novum IQBAXTER HEALTHCARE CORPORATIONLZH2025-07-07
00704411019797SENTINEL® Enteral Feeding PumpAMSINO INTERNATIONAL, INC.LZH2025-06-25
03660812138345PUGGLEMEDWIN FRANCELZH2025-06-11
53660812136780PUGGLEMEDWIN FRANCELZH2025-06-11
10192253011135KangarooCardinal Health 200, LLCLZH2025-05-28
50192253011133KangarooCardinal Health 200, LLCLZH2025-05-28
10192253008456KangarooCardinal Health 200, LLCLZH2025-05-19
50192253008454KangarooCardinal Health 200, LLCLZH2025-05-19
10192253009682KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009859KangarooCardinal Health 200, LLCLZH2025-05-02
10192253009965KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009680KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009857KangarooCardinal Health 200, LLCLZH2025-05-02
50192253009963KangarooCardinal Health 200, LLCLZH2025-05-02
10192253008418KangarooCardinal Health 200, LLCLZH2025-04-29
10192253008432KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008416KangarooCardinal Health 200, LLCLZH2025-04-29
50192253008430KangarooCardinal Health 200, LLCLZH2025-04-29
10885380184567KangarooCardinal Health 200, LLCLZH2025-03-23
10192253008159KangarooCardinal Health 200, LLCLZH2024-12-16
10192253023107KangarooCardinal Health 200, LLCLZH2024-12-16