FDA.report

NAMIC

Primary DI
H74904494102
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
0449410
Device description
Essentials Kit
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
DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC

Product Code Classifications

CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Premarket Submissions

SubmissionSupplement
K951802000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K951802000SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KITScimed Life Systems, Inc.1995-07-21DXT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H74904494102PackageHIBCC10In Commercial Distribution
H74904494100PrimaryHIBCC0

GMDN Terms

TermDefinition
StopcockA general-purpose valve that is used to regulate the direction of a liquid or a gas flow. It is typically constructed of a durable material, e.g., plastic and/or metal, and may be used for a variety of general-purpose uses. For stopcocks used in intravenous (IV) lines for injection or removal of fluids see the appropriate GMDN code. This is a single-use device.

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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