FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40889942856009
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJCTRST30ML
Catalog number
DYNJCTRST30ML
Device description
MANAGER CONTRAST 72IN TBG
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
FPASet, administration, intravascular
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2
OEQAngiography/Angioplasty KitCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K982123000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K982123000CONTRAST CONTROL DEVICEMedex, Inc.1998-07-21FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40889942856009PackageGS120In Commercial Distribution
10889942856008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088994285600940889942856009
1088994285600810889942856008

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
10080196158652MEDLINE INDUSTRIES, INC.MDS139000MDS1390002026-07-16
10884389101551MEDLINEMDS160684MDS1606842016-10-14
10884389101575MEDLINEMDS160860MDS1608602016-10-14
10884389101674MEDLINEMDS160820MDS1608202016-10-14
10884389101704MEDLINEMDS160828MDS1608282016-10-14
10884389101728MEDLINEMDS160628MDS1606282016-10-14
10884389191613MEDLINEMDS160604MDS1606042016-10-14
10080196456765MEDLINEVDYND20302VDYND203022026-07-14
10080196031764MEDLINEDYND20125DYND201252026-07-13
10197344175963MEDLINEESS7012EPESS7012EP2026-07-13
10197344175970MEDLINEESS7022EPESS7022EP2026-07-13
10197344175987MEDLINEESS7044EPESS7044EP2026-07-13
10197344176007MEDLINEESS9022EPESS9022EP2026-07-13
10197344176014MEDLINEESS9045EPESS9045EP2026-07-13
10197344176021MEDLINEESS9048EPESS9048EP2026-07-13
10197344176038MEDLINEESS9066EPESS9066EP2026-07-13
10197344214723MEDLINEHCSLADYBUGSOLHCSLADYBUGSOL2026-07-13
20193489108214MEDLINEMDTZ1017073CAMDTZ1017073CA2026-07-13
20197344219435MEDLINEMDT2168056XGVMDT2168056XGV2026-07-13
20888277636559MEDLINEMDTZ1017073ABMDTZ1017073AB2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956439603CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956499560CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956511620CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956526068CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956526839CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956527928CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10198956529335CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-16
10809160527283HalyardAVID MEDICAL, INC.OEQ2026-07-16
10809160527290HalyardAVID MEDICAL, INC.OEQ2026-07-16
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
00884450487341Merit Medical®Merit Medical Systems, Inc.OEQ2026-07-10
10198956307308CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956349834CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956368163CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956470897CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956483651CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956485143CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956491588CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956499959CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956504035CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956517752CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956521650CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956524750CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525580CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956525832CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956526174CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527249CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527645CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956527744CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09
10198956528086CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-07-09