Exacta™ 680128/A

GUDID 20884450321052

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.

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Primary Device ID	20884450321052
NIH Device Record Key	01f3818e-e7f6-4b39-a822-7fbcd04fe851
Commercial Distribution Status	In Commercial Distribution
Brand Name	Exacta™
Version Model Number	10884450321055
Catalog Number	680128/A
Company DUNS	595138793
Company Name	ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450321058 [Unit of Use]
GS1	10884450321055 [Primary]
GS1	20884450321052 [Package] Contains: 10884450321055 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K941428

FDA Product Code

DYB	INTRODUCER, CATHETER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-06-11
Device Publish Date	2019-06-03

On-Brand Devices [Exacta™]

20884450321045	10884450321048
20884450321052	10884450321055
20884450389991	10884450389994
20884450321069	10884450321062
20884450321038	10884450321031

Trademark Results [Exacta]

Mark Image Registration \| Serial	Company Trademark Application Date
EXACTA 90578735 not registered Live/Pending	Exacta Systems, LLC 2021-03-15
EXACTA 90578726 not registered Live/Pending	Exacta Systems, LLC 2021-03-15
EXACTA 88458205 5897318 Live/Registered	Medtronic, Inc. 2019-06-04
EXACTA 87701650 not registered Dead/Abandoned	Sacks Holdings, Inc. 2017-11-29
EXACTA 87096372 5169943 Live/Registered	Haddad, Esther 2016-07-07
EXACTA 86772276 4960074 Live/Registered	Schwartz, Carl I. 2015-09-29
EXACTA 86533748 5576135 Live/Registered	Kimberly Jones 2015-02-12
EXACTA 81008357 1008357 Dead/Cancelled	U.S. Suzuki Motor Corporation 0000-00-00
EXACTA 78714326 3135721 Dead/Cancelled	Experiencia, Inc. 2005-09-16
EXACTA 78239770 not registered Dead/Abandoned	SpectraVerse, Inc. 2003-04-19
EXACTA 77140103 3539340 Live/Registered	Fiocchi of America, Inc. 2007-03-26
EXACTA 76641511 3184307 Live/Registered	Anderson, Joseph M. 2005-06-13