NAMIC

Primary DI
20193489068181
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
90400039
Catalog number
90400039
Device description
CONTRAST CONTROLLER SPIKE ASM. PG
Published
2023-12-21
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZISystem, x-ray, angiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZISystem, X-Ray, AngiographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903493000NAMIC CONTRAST SAVINGS DELIVERY SYSTEMNorth American Instrument Corp.1991-03-26IZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489068181PackageGS125In Commercial Distribution
10193489068184PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348906818120193489068181
1019348906818410193489068184

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium conservation systemAn assembly of electromechanical devices that serves a contrast medium injector system by controlling the amount of contrast agent supplied to the syringe/injector portion of the contrast medium injector system. It is designed to optimise the use of injectible contrast agents in order to prevent unnecessary waste of contrast media during and/or between patient procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197344129099CURADCURCHSIL0753CURCHSIL07532026-06-09
00197344133812MEDLINEFRES2500FRES25002026-06-09
00197344133836MEDLINEFRES2501FRES25012026-06-09
00197344133850MEDLINEFRES2502FRES25022026-06-09
00197344133874MEDLINEFRES2503FRES25032026-06-09
00197344133898MEDLINEFRES2504FRES25042026-06-09
10197344142460MEDLINERTACHACMBRTACHACMB2026-06-09
10197344142477MEDLINERTACHACMGRTACHACMG2026-06-09
10197344142484MEDLINERTACHACMNRTACHACMN2026-06-09
10197344142491MEDLINERTACHACMPRTACHACMP2026-06-09
10197344142507MEDLINERTACHACMRRTACHACMR2026-06-09
10197344142514MEDLINERTACHACMYRTACHACMY2026-06-09
10197344142521MEDLINERTACHACMZRTACHACMZ2026-06-09
10197344143306MEDLINERTACHDAABRTACHDAAB2026-06-09
10197344143313MEDLINERTACHDAAGRTACHDAAG2026-06-09
10197344143320MEDLINERTACHDAANRTACHDAAN2026-06-09
10197344143337MEDLINERTACHDAAPRTACHDAAP2026-06-09
10197344143344MEDLINERTACHDAARRTACHDAAR2026-06-09
10197344143351MEDLINERTACHDAAYRTACHDAAY2026-06-09
10197344143368MEDLINERTACHDAAZRTACHDAAZ2026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841962120548Alpine Stirrups, Metric, LeftQfixIZI2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixIZI2026-04-14
00841962120388Lumen AirShuttleQfixIZI2025-12-02
08600105136202RE3Digital Surgery Systems, Inc.IZI2025-07-15
10193489068184NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068191NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
10193489068207NAMICMEDLINE INDUSTRIES, INC.IZI2023-12-21
00195278719263AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719577AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719720AlliaGE MEDICAL SYSTEMSIZI2023-12-08
00195278719744AlliaGE MEDICAL SYSTEMSIZI2023-12-08
10193489068092MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10193489140170MEDLINEMEDLINE INDUSTRIES, INC.IZI2023-09-15
10841962118733Iris AirShuttle™QfixIZI2023-04-10
00195278485144AlliaGE MEDICAL SYSTEMSIZI2022-04-13
00195278485168AlliaGE MEDICAL SYSTEMSIZI2022-04-08
00860001790290SterimedSTERIMED LLCIZI2021-09-29
00860007655609SterimedSTERIMED LLCIZI2021-09-29
10193489058826NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489058833NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059038NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
10193489059458NAMICMEDLINE INDUSTRIES, INC.IZI2021-07-26
20193489066927NAMICMEDLINE INDUSTRIES, INC.IZI2021-05-12
00195278215543AlliaGE MEDICAL SYSTEMSIZI2021-03-31
00195278215550AlliaGE MEDICAL SYSTEMSIZI2021-03-31
10858701006213SPYNovadaq Technologies IncIZI2020-09-21
00860001790214SterimedSTERIMED LLCIZI2020-04-27
00810116023011Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00810116023028Dornier MedTechDORNIER MEDTECH AMERICA, INC.IZI2020-03-17
00840682147378INNOVAGE MEDICAL SYSTEMSIZI2020-02-03