FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489499438
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ35300J
Catalog number
DYNJ35300J
Device description
CARDIAC CATH PACK MRH-LF
Published
2021-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489499439PackageGS13In Commercial Distribution
10193489499438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348949943940193489499439
1019348949943810193489499438

GMDN Terms#

Term, Definition table
TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098DDS1159D0Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-26
10198459754210MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459754524MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755699MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459755705MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758287MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459758294MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459759291MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459761850MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459766336MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459771224MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459774126MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775437MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775666MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775673MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459775680MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459778827MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459779985MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459784996MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459786808MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459787690MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459788130MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459789717MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459789724MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459791994MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459792007MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459795138MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459796975MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459799143MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25
10198459809187MEDLINEMEDLINE INDUSTRIES, INC.OES2026-09-25