BIOSITE / BIOSITE PLUS JR-009-HU

GUDID 00810083350844

JR-009-HU 300 psi High Pressure Needleless Neutral Valve

Sensimedical LLC

Intravenous administration tubing extension set
Primary Device ID00810083350844
NIH Device Record Key216e71b6-c5bc-455f-9980-6101deae6b68
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOSITE / BIOSITE PLUS
Version Model NumberJR-009-HU
Catalog NumberJR-009-HU
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
GS100810083350837 [Primary]
GS100810083350844 [Package]
Contains: 00810083350837
Package: [250 Units]
In Commercial Distribution
GS100810083350851 [Package]
Package: [1000 Units]
In Commercial Distribution

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 [BIOSITE / BIOSITE PLUS]

00810083350844JR-009-HU 300 psi High Pressure Needleless Neutral Valve
00810083350431JR-009-TU 60 psi Transparent Needleless Neutral Valve

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