WOLF-PACK / BIOSITE / BIOSITE PLUS BI8000

GUDID 00810083350257

BI8000 Biosite Plus 60 psi Transparent Needleless Neutral Valve

Sensimedical LLC

Intravenous administration tubing extension set
Primary Device ID00810083350257
NIH Device Record Key45761781-8579-400c-8dbb-c18d21593c18
Commercial Distribution StatusIn Commercial Distribution
Brand NameWOLF-PACK / BIOSITE / BIOSITE PLUS
Version Model NumberBI8000
Catalog NumberBI8000
Company DUNS117526048
Company NameSensimedical LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810083350240 [Package]
Package: [1000 Units]
In Commercial Distribution
GS100810083350257 [Package]
Contains: 00810083350813
Package: [100 Units]
In Commercial Distribution
GS100810083350813 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FPASet, Administration, Intravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-12
Device Publish Date2024-01-04

On-Brand Devices [WOLF-PACK / BIOSITE / BIOSITE PLUS]

00810083350370BI8500 60 psi Transparent Needleless Neutral Valve
00810083350257BI8000 Biosite Plus 60 psi Transparent Needleless Neutral Valve
00810083350400BI8504 Opaque Biosite Plus Neutral Pressure Needleless Valve w/14" Microbore Extension
00810083350394BI8002 Clear Biosite Plus Neutral Pressure Needleless Valve w/8" Microbore Extension
00810083350387BI8502 Opaque Biosite Plus Neutral Pressure Needless Valve w/8" Microbore Extension
00810083350417BI8004 Clear Biosite Plus Neutral Pressure Needless Valve w/14" Microbore Extension

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