R.O.S.E™ 682105/A

GUDID 20884450322639

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

Invasive blood pressure monitoring tubing set
Primary Device ID20884450322639
NIH Device Record Key3d9a5792-1430-45d5-afed-24a617533d9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameR.O.S.E™
Version Model Number10884450322632
Catalog Number682105/A
Company DUNS595138793
Company NameARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884450322635 [Unit of Use]
GS110884450322632 [Primary]
GS120884450322639 [Package]
Contains: 10884450322632
Package: [10 Units]
In Commercial Distribution

FDA Product Code

DRSTransducer, blood-pressure, extravascular

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-12-13
Device Publish Date2018-01-26

Devices Manufactured by ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

20884450360631 - Meritrans DTXPlus®2024-09-16
10884450330750 - Merit Medical®2024-01-22
20884450387768 - Merit Medical®2023-05-04
20884450388161 - Merit Medical®2023-03-13
10884450330798 - Merit Medical®2022-09-28
20884450321502 - Careflow™2022-09-28
20884450387751 - Merit Medical®2022-06-24
20884450385160 - Meritrans DTXPlus®2022-06-16

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