FDA.report

MaxGuard

Primary DI
20885403237550
Brand
MaxGuard
Company
CAREFUSION 303, INC.
Model
MX5301
Catalog number
MX5301
Device description
MaxGuard pressure rated extension set with 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

Related Records

Contact Domains

Product Codes

CodeName
FPASet, administration, intravascular

Product Code Classifications

CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20885403237550PackageGS112In Commercial Distribution
50885403237551PrimaryGS10
10885403237553Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088540323755020885403237550
5088540323755150885403237551
1088540323755310885403237553

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit125 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

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

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