FDA.report

NAMIC

Primary DI
30193489066078
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
70097107
Catalog number
70097107
Device description
SYRINGE,12ML,PP/FG,RA,W/RES,-,PKG
Published
2024-03-05
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
DXTInjector and syringe, angiographic

Product Code Classifications

CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2

Premarket Submissions

SubmissionSupplement
K873955000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K873955000NAMIC ANGIOGRAPHIC SYRINGENorth American Instrument Corp.1988-02-05DXT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489066071PackageGS110In Commercial Distribution
30193489066078PackageGS180In Commercial Distribution
10193489066074PrimaryGS10

GMDN Terms

TermDefinition
Angiographic syringeA sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. 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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