FDA.report

NAMIC

Primary DI
H965808000030
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
80800003
Device description
Male Luer Lock Fitting for SOSA Tubing
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions

SubmissionSupplement
K842829000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K842829000HIGH PRESSURE, 1 & 3 WAY STERILE DISPOSNorth American Instrument Corp.1984-10-18DTL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H965808000030PrimaryHIBCC0

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
Ethylene Oxide

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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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