FDA.reportPublic FDA data

MaxGuard, MaxPlus

Primary DI
20885403274609
Brand
MaxGuard, MaxPlus
Company
CAREFUSION 303, INC.
Model
MP9262-C
Catalog number
MP9262-C
Device description
MaxGuard multi-fuse extension set with needleless connector (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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051499000INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SETMedegen Medical Manufacturing Services2005-06-22FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885403274609PackageGS112In Commercial Distribution
50885403274600PrimaryGS10
10885403274602Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088540327460920885403274609
5088540327460050885403274600
1088540327460210885403274602

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
Special Storage Condition, Specify00Room Temperature
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
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
10885403519666BD Alaris™ System Manager 9601, Software96019601ASMSW12522024-06-19
10885403510472BD Alaris™ Infusion Adapter, SoftwareNot ApplicableINFADPTSW1722022-08-12
10885403510489BD Alaris™ Calculation Services, SoftwareNot ApplicableCALCSRVSW1112022-06-09
10885403520761BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1262025-09-10
10885403516054BD Alaris™ ETCO2 Module, Model 830083008300BDADXEN1232023-09-18
10885403830013Alaris83002016-12-08
10885403830020Alaris83002021-10-08
10885403519475BD Alaris83008300SW12602025-12-23
10885403211423Alaris™ Pump Module, Model 81008100109386622025-12-19
10885403423208Alaris™ Syringe Module, Model 811081008110SIXEN8562025-12-19
10885403237867BD MaxGuardMY3003MY30032016-09-22
10885403533228BD Pyxis3232025-11-14
10885403533235BD Pyxis3242025-11-14
10885403533242Pyxis3273272025-11-14
10885403532528Pyxis Pro MedStation177-255177-2552025-10-17
10885403516023BD Alaris™ PCU Module, Model 801580158015BDCDXEN12312023-09-18
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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07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
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08498840010389Churchill Medical SystemsVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
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