FDA.report

NAMIC

Primary DI
10193489066920
Company
MEDLINE INDUSTRIES, INC.
Model
80400839
Catalog number
80400839
Device description
CONTRAST CONT ELONG SPIKE ASSY-OEM
Published
2021-05-12
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

Regulatory Flags

DUNS number
025460908
Device count
100
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
20193489066927PrimaryGS10
10193489066920Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
20193489066927PrimaryGS10
10193489066920Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
IZISystem, X-Ray, Angiographic2Radiology892.1600NEligible

Premarket Submissions

SubmissionSupplement
K903493000

Premarket Details

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

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.

Device Sizes

TypeValueText
Device Size Text, specify0FALSE

Storage And Handling

No records found.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

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