FDA.reportPublic FDA data

MaxGuard

Primary DI
50885403237582
Brand
MaxGuard
Company
CAREFUSION 303, INC.
Model
MX9059
Catalog number
MX9059
Device description
MaxGuard extension set with needleless Y-site(s)
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403237582PrimaryGS10
10885403237584Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540323758250885403237582
1088540323758410885403237584

GMDN Terms#

Term, Definition table
TermDefinition
Intravenous administration tubing extension setA collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. 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.co

Regulatory Flags#

DUNS number
360624720
Device count
50
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
10885403519475BD Alaris83008300SW12602025-12-23
10885403211423Alaris™ Pump Module, Model 81008100109386622025-12-19
10885403423208Alaris™ Syringe Module, Model 811081008110SIXEN8562025-12-19
10885403533235BD Pyxis3242025-11-14
10885403533242Pyxis3273272025-11-14
10885403520761BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1262025-09-10
10885403521836Pyxis Pro MedStation177-216177-2162025-08-01
10885403521966Pyxis Pro MedStationSW-MS-ES-PRO-V48SW-MS-ES-PRO-V482025-08-01
10885403237867MaxGuardMY3003MY30032016-09-22
10885403521935Pyxis MedStationSW-MS-ES-V48SW-MS-ES-V482025-07-23
10885403519291BD Alaris80158015BDDDXEN12502025-06-25
10885403517822Pyxis Pro MedStation1149-001149-002025-06-05
10885403517839Pyxis Pro MedStation1152-001152-002025-06-05
10885403521225Pyxis Pro MedStation177-25177-252025-06-05
10885403521263Pyxis Pro MedStation177-114177-1142025-06-05
10885403521270Pyxis Pro MedStation177-138177-1382025-06-05
10885403521287Pyxis Pro MedStation177-148177-1482025-06-05
10885403521294Pyxis Pro MedStation177-184177-1842025-06-05
10885403521300Pyxis Pro MedStation1155-001155-002025-06-05
10885403522451Pyxis Pro MedStation177-14177-142025-06-05

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Primary DI, Brand, Company table
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B21257700W2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
B21257700Y2Luer Lock CapINTERNATIONAL MEDICAL INDUSTRIES INC.FPA2026-01-23
00813153028179CodanCodan US CorporationFPA2026-01-21
10801741239189PowerLocBard Access Systems, Inc.FPA2026-01-20
10801741239196MiniLocBard Access Systems, Inc.FPA2026-01-20
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