FDA.report

Merit Medical®

Primary DI
00884450337066
Brand
Merit Medical®
Company
Merit Medical Systems, Inc.
Model
00884450337066
Catalog number
K09T-12020B
Published
2018-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OEZCardiovascular procedure kit

Product Code Classifications

CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00884450337066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00884450337066008844503370668844503370660884450337066

GMDN Terms

TermDefinition
Contrast medium injection system manifold kitA collection of sterile devices designed to provide an interface between a contrast medium injection system and an angiographic patient catheter for the delivery of a contrast medium or saline solution to a patient undergoing a diagnostic imaging procedure. It is intended to maximize the creation of the optimal connection for fluid delivery. It typically consists of an injection fitting that is connected to the contrast medium injection system, a pressure transducer cartridge, a check valve and tubing; it is typically made of plastic materials. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
603160040
Device count
1
DM exempt
false
Premarket exempt
true
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

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