FDA.reportPublic FDA data

Alaris, SmartSite

Primary DI
50885403233744
Brand
Alaris, SmartSite
Company
CAREFUSION 303, INC.
Model
10012564
Catalog number
10012564
Device description
SmartSite Gravity Burette 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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951922000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951922000ADMINISTRATION SETS WITH BALL FLOATImed Corp.1995-07-19FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403233744PrimaryGS10
10885403233746Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323374450885403233744
1088540323374610885403233746

GMDN Terms#

Term, Definition table
TermDefinition
Burette intravenous administration setA collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system, that includes a calibrated burette for fluid volume measurement. The collection also typically includes tubing, connectors, clamps, and injection ports. It may be used for gravitational intravenous administration or with an infusion 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
10
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
true
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

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