FDA.reportPublic FDA data

SY12-RPR

Primary DI
00886333622535
Brand
SY12-RPR
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682253
Catalog number
682253
Device description
12mL with Male Luer Taper Syringe
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQFActuator, Syringe, Injector Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQFActuator, Syringe, Injector TypeCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333622530PackageGS150In Commercial Distribution
00886333622535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362253050886333622530
00886333622535008863336225358863336225350886333622535

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
595138793
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884450321505Careflow™10884450321505681631/A2022-09-20
10884450321567Careflow™108844503215672018-07-19
10884450321598Careflow™108844503215982018-07-19
10884450363956RadialFlo™108844503639562019-02-28
10884450322557Meritrans DTXPlus®108844503225572018-01-26
10884450322564Meritrans DTXPlus®108844503225642018-01-26
10884450323905Critiflo™108844503239052018-01-30
10884450326463Merit Medical®108844503264632018-01-26
10884450360467Merit Medical®108844503604672018-08-06
10884450360474Merit Medical®108844503604742018-12-13
10884450360481Merit Medical®108844503604812018-09-10
10884450360498Merit Medical®108844503604982018-03-19
10884450360504Merit Medical®108844503605042018-05-22
10884450360511Merit Medical®108844503605112018-09-17
10884450360535Meritrans DTXPlus®108844503605352018-12-03
10884450360689Meritrans DTXPlus®108844503606892018-02-14
10884450360702Meritrans DTXPlus®108844503607022018-11-06
10884450360764Meritrans DTXPlus®108844503607642018-04-11
10884450360825Meritrans DTXPlus®108844503608252018-05-01
10884450371753Meritrans DTXPlus®108844503717532019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886333622429SY12-RTRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622498SY10-RTRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622504SY10-RPRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622511SY10-RTARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622528SY10-RPARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622542SY12-RTARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622559SY12-RPARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
00886333622566SY12-LTRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622424SY12-RTRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622493SY10-RTRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622509SY10-RPRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622516SY10-RTARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622523SY10-RPARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622530SY12-RPRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622547SY12-RTARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622554SY12-RPARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30
50886333622561SY12-LTRARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DQF2016-09-30