FDA.reportPublic FDA data

BIOSITE/BIOSITE PLUS

Primary DI
B134BI85001
Brand
BIOSITE/BIOSITE PLUS
Company
MACLIN POWER, INC.
Model
BI8500
Catalog number
BI8500
Device description
BI8500 60 PSI Transparent Needleless Neutral Valve
Published
2016-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
B134BI85002PackageHIBCC10In Commercial Distribution
B134BI85001PrimaryHIBCC0
B134BI85000Unit of UseHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962650714
Device count
100
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B134BI80001BIOSITE/BIOSITE PLUSBI8000BI80002018-02-14
B134BI80022BIOSITE/BIOSITE PLUSBI8002 BI8002 2017-04-07
B134BI80042BIOSITE/BIOSITE PLUSBI8004BI80042018-02-14
B134BI85022BIOSITE/BIOSITE PLUSBI8502BI85022017-04-07
B134BI85042BIOSITE/BIOSITE PLUSBI8504BI85042017-04-07
B134JR009HU2BIOSITE/BIOSITE PLUSJR-009-HUJR-009-HU2016-12-30
B134JR009TU2BIOSITE/BIOSITE PLUSJR-009-TUJR-009-TU2016-12-30
B134JR010AU2BIOSITE/BIOSITE PLUSJR-010-AUJR-010-AU2018-02-14
B134JR011AU2BIOSITE/BIOSITE PLUSJR-011-AUJR-011-AU2018-02-14
B134JR012AU2BIOSITE/BIOSITE PLUSJR-012-AUJR-012-AU2018-02-14
B134JR012CU2BIOSITE/BIOSITE PLUSJR-012-CUJR-012-CU2018-02-14
B134JR014AU2BIOSITE/BIOSITE PLUSJR-014-AUJR-014-AU2018-02-14
B134JR015AU2BIOSITE/BIOSITE PLUSJR-015-AUJR-015-AU2018-02-14
B134JR016AU2BIOSITE/BIOSITE PLUSJR-016-AUJR-016-AU2018-02-14
B134JR017AU2BIOSITE/BIOSITE PLUSJR-017-AUJR-017-AU2016-12-30
B134JR018LU2BIOSITE/BIOSITE PLUSJR-018-LUJR-018-LU2018-02-14
B134JR018SU2BIOSITE/BIOSITE PLUSJR-018-SUJR-018-SU2018-02-14
B134JR019AU2BIOSITE/BIOSITE PLUSJR-019-AUJR-019-AU2018-02-14
B134JR020LU2BIOSITE/BIOSITE PLUSJR-020-LUJR-020-LU2018-02-14
B134JR020SU2BIOSITE/BIOSITE PLUSJR-020-SUJR-020-SU2018-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153028329CodanCodan US CorporationFPA2026-07-17
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05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018626LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018633LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018640LifeguardAngiodynamics, Inc.FPA2026-06-23
00811505030573IvenixFresenius Kabi AGFPA2026-06-02
04046955836383Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
04046955836406Infusomat®B. BRAUN MEDICAL INC.FPA2024-08-15
00382905168031BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
00382905168000BD Intelliport SystemBECTON, DICKINSON AND COMPANYFPA2024-06-07
04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
00085412676630DUO-VENTBAXTER HEALTHCARE CORPORATIONFPA2023-07-11
00634624911109Precision Delivery Bifurcated IV Extension SetQUEST MEDICAL INCFPA2022-12-19
00634624911048High-Flow Extension SetQUEST MEDICAL INCFPA2022-12-12
00634624101159Q2 IV Administration SetQUEST MEDICAL INCFPA2022-12-06