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
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10198956513587CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956553422CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956591677CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956594395CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956607712CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956608641CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956611320CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613294CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956613522CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956614789CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
10198956615540CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-19
00884450037911Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-17
10198956571495CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956599406CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956606869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956607446CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
00884450501832Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-14
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956587243CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12