MaxZero

Primary DI
20885403230193
Brand
MaxZero
Company
CAREFUSION 303, INC.
Model
MZ1000-07
Catalog number
MZ1000-07
Device description
MaxZero Needleless Connector
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
K132413000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132413000MZ1000Care Fusion2013-08-29FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403230193PackageGS124In Commercial Distribution
50885403230194PrimaryGS10
10885403230196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540323019320885403230193
5088540323019450885403230194
1088540323019610885403230196

GMDN Terms#

Term, Definition table
TermDefinition
Neutral-pressure needleless valve-connectorA small, sterile, stand-alone, Luer-activated needleless plastic valve intended to mate two related intravenous (IV) line devices [e.g., hypodermic syringe and catheter port or tubing from an IV administration set] and hold them in a secured, sealed, locked position until disconnection, at which point there is minimal fluid flow into or out of the catheter/tubing. It is intended to eliminate the use of needles for IV administration of medications. 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
+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
true
Sterilization required before use
false

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10885403211423Alaris™ Pump Module, Model 81008100109386622025-12-19
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10885403237867BD MaxGuardMY3003MY30032016-09-22
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10885403533235BD Pyxis3242025-11-14
10885403533242Pyxis3273272025-11-14
10885403532528Pyxis Pro MedStation177-255177-2552025-10-17
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10885403515316Alaris™ PCA Module, Model 812081208120FDXEN12122023-06-20
10885403515231BD Alaris™ PCU Module, Model 801580158015BDMDXEN12132023-06-08
10885403515323BD Alaris™ Syringe Module, Model 811081108110FDXEN12122023-06-08
10885403516047BD® Alaris™ Syringe Module, Model 811081108110BDADXEN1232023-09-12

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