FDA.reportPublic FDA data

TA2100 ANGIOGRAPHIC MANIFOLD

Primary DI
00886333621101
Brand
TA2100 ANGIOGRAPHIC MANIFOLD
Company
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
Model
682110
Catalog number
682110
Device description
3-Way Left OFF Directed 2 Ports Manifold
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50886333621106PackageGS1125In Commercial Distribution
00886333621101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088633362110650886333621106
00886333621101008863336211018863336211010886333621101

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
595138793
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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20884450628304Merit Medical®B6821062024-12-07
20884450360631Meritrans DTXPlus®B6820012024-09-06
10884450330750Merit Medical®00884450330753684063/A2024-01-12
20884450387768Merit Medical®10884450387761682078/B2023-04-26
20884450388161Merit Medical®10884450388164682275/B2023-03-03
10884450330798Merit Medical®00884450330791684085/A2022-09-20
20884450321502Careflow™10884450321505681631/A2022-09-20
20884450387751Merit Medical®10884450387754682075/B2022-06-16
20884450385160Meritrans DTXPlus®10884450385163682034/B2022-06-08
20884450372085Merit Medical®10884450372088682077/B2022-04-26
00884450323267Meritrans DTXPlus®10884450323264683019/A2022-03-04
20884450619289Meritrans DTXPlus®10884450619282689887/B2022-02-28
20884450619296Safedraw™10884450619299689844/B2022-02-28
20884450621152Safedraw™10884450621155689883/B2022-02-28
20884450371774Meritrans DTXPlus®10884450371777682012/B2022-02-18
10884450361037Merit Medical®00884450361030684061/A2022-01-19
20884450321885Careflow™10884450321888681718/A2022-01-10
10884450361013Merit Medical®00884450361016684045/A2020-11-13
20884450320901Critikit™10884450320904680000/A2018-01-30

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