FDA.report

MaxGuard

Primary DI
20885403237413
Brand
MaxGuard
Company
CAREFUSION 303, INC.
Model
MV0510
Catalog number
MV0510
Device description
MaxGuard single dose vial access spike
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
20885403237413PackageGS112In Commercial Distribution
50885403237414PrimaryGS10
10885403237416Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088540323741320885403237413
5088540323741450885403237414
1088540323741610885403237416

GMDN Terms

TermDefinition
Fluid transfer set, general-purposeA collection of sterile devices and supplies designed to transfer several types of medical fluids (e.g., drugs, vaccines, blood, and solutions) between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. 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
+1(800)854-7128CustCareInfusion@carefusion.com
+1(844)823-5433customer_support@bd.com

Regulatory Flags

DUNS number
360624720
Device count
100
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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