BIOSITE/BIOSITE PLUS JR-011-AU

GUDID 00810083350912

JR-011-AU Biosite Regular Set

Sensimedical LLC

Intravenous administration tubing extension set
Primary Device ID00810083350912
NIH Device Record Keyfb61234e-87a9-414c-99f2-9b68dd1a7c65
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOSITE/BIOSITE PLUS
Version Model NumberJR-011-AU
Catalog NumberJR-011-AU
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
GS100810083350912 [Package]
Contains: 00810083350929
Package: Master Case [200 Units]
In Commercial Distribution
GS100810083350929 [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 Date2024-06-05
Device Publish Date2024-05-28

On-Brand Devices [BIOSITE/BIOSITE PLUS]

00810083350974JR-020-LU Biosite Pediatric Bifurcated Extension Tube - Luer Lock
00810083350967JR-024-AU Biosite Adult Bifurcated Extension Tube
00810083350936JR-014-AU Biosite Adult Extension Tube
00810083350912JR-011-AU Biosite Regular Set
00810083350899JR-015-AU Biosite Surgical Set with Check Valve
00810083350516JR-044-AU Biosite Transfer Spike
00810083350455JR-017-AU Biosite Extension with Solution Filter

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