FDA.report

NAMIC

Primary DI
H749904004351
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
90400435
Device description
SQUEEZE CONTRAST CONTROLLER 72"
Published
2016-09-20
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

Related Records

Product Codes

CodeName
IZISystem, x-ray, angiographic

Product Code Classifications

CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions

SubmissionSupplement
K903493000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K903493000NAMIC CONTRAST SAVINGS DELIVERY SYSTEMNorth American Instrument Corp.1991-03-26IZI

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H749904004351PackageHIBCC10In Commercial Distribution
H749904004350PrimaryHIBCC0

GMDN Terms

TermDefinition
Contrast medium conservation systemAn assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures.

Device Sizes

TypeValueUnit
Length72Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags

DUNS number
809699023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
Sterilization required before use
false

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