FDA.report

NAMIC

Primary DI
20193489058878
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
64000127
Catalog number
64000127
Device description
Y ADAPTOR LG BORE FINE THREAD BOTTLE
Published
2021-07-26
Public version status
New
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
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications

CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions

SubmissionSupplement
K900652000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K900652000NAMIC PTCA Y-ADAPTORNorth American Instrument Corp.1990-06-26DTL

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489058878PackageGS15In Commercial Distribution
10193489058871PrimaryGS10

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(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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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