FDA.reportPublic FDA data

SF-NIH

Primary DI
10887714024518
Brand
SF-NIH
Company
NUMED, INC.
Model
317
Catalog number
SF360
Device description
A single lumen catheter used for injection of radiopaque media and pressure measurements of cardiovascular vessels / chambers.
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952984000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952984000MAP MULTITRACK ANGIOGRAPHIC CATHETER (4F)Map Medical Equipment, Inc.1996-01-29DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10887714024518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088771402451810887714024518

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic catheter, single-useA thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
114186877
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887714024990REBOA Catheter362RB2020302016-09-20
10887714012140Tearduct Catheter352TD1002016-09-20
10887714024525SF-NIH317SF4602016-09-15
10887714024549REBOA Catheter362RB1530302016-09-16
10887714024556REBOA Catheter362RB1530502016-09-16
10887714024563REBOA Catheter362RB1530702016-09-16
10887714024570REBOA Catheter362RB1540302016-09-16
10887714024587REBOA Catheter362RB1540502016-09-16
10887714024594REBOA Catheter362RB1540702016-09-16
10887714024600REBOA Catheter362RB2030302016-09-19
10887714024617REBOA Catheter362RB2030502016-09-19
10887714024624REBOA Catheter362RB2030702016-09-19
10887714024631REBOA Catheter362RB2040302016-09-19
10887714024648REBOA Catheter362RB2040502016-09-19
10887714024655REBOA Catheter362RB2040702016-09-19
10887714024662REBOA Catheter362RB2530302016-09-19
10887714024679REBOA Catheter362RB2530502016-09-19
10887714024686REBOA Catheter362RB2530702016-09-19
10887714024693REBOA Catheter362RB2540302016-09-19
10887714024709REBOA Catheter362RB2540502016-09-19

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