FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40889942447078
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJCTRST15ML
Catalog number
DYNJCTRST15ML
Device description
CONTRAST SAVER 15ML CHAMBER
Published
2022-08-04
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
DQOCatheter, intravascular, diagnostic
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
OEQAngiography/Angioplasty KitCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932141000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932141000CARDIAC CATHETERIZATION KITAbbott Laboratories1994-09-22DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942447078PackageGS120In Commercial Distribution
10889942447077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994244707840889942447078
1088994244707710889942447077

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10197344039791MEDLINEHNX22075HNX220752024-10-11
10197344039807MEDLINEHNX22100HNX221002024-10-11
10888277348226MEDLINEMDS630S2MDS630S22026-07-29
10888277699472MEDLINEDYND300010SDYND300010S2026-07-29
10888277699489MEDLINEDYND300015SDYND300015S2026-07-29
10888277699496MEDLINEDYND300020SDYND300020S2026-07-29
10888277699502MEDLINEDYND300025SDYND300025S2026-07-29
10888277699533MEDLINEDYND300050SDYND300050S2026-07-29
10888277701588MEDLINEMSC9912EPMSC9912EP2025-09-24
10888277701595MEDLINEMSC9918EPMSC9918EP2025-09-24
10888277701618MEDLINEMSC9945EPMSC9945EP2025-09-24
10888277701625MEDLINEMSC9948EPMSC9948EP2025-09-24
10888277701632MEDLINEMSC9966EPMSC9966EP2025-09-24
10888277701649MEDLINEMSC99812EPMSC99812EP2025-09-24
30193489103964MEDLINE1202YLW3AOS2026-07-28
30193489103971MEDLINE1202YLW3XL2026-07-28
10197344216123MEDLINESSBCS21GLSSBCS21GL2026-07-24
10197344219575MEDLINEMDS99905MDS999052026-07-24
10653160391326MEDLINEEBSI1865EBSI18652026-07-24
30193489017742MEDLINE6651CBL22X16651CBL22X12026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450117156Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486191Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450486207Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-30
00884450487921Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-29
00885403522393Swan-GanzBecton, Dickinson And CompanyDQO2026-07-27
10198956323087CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956352377CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956353572CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956446816CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956474048CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956481350CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956489172CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956494527CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956505124CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956511309CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956512627CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956517196CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956517325CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956519213CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956521698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956523951CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956528796CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956528888CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956529045CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956529205CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956530522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956530546CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956531246CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956531345CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27
10198956533387CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-27