FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
10193489860719
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ61169A
Catalog number
DYNJ61169A
Device description
CHRISTUS CH PEDIATRIC HEART PK
Published
2021-04-04
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
OEZCardiovascular procedure kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEZCardiovascular Procedure KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10193489860719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1019348986071910193489860719

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
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888277417205MEDLINEMSG9460MSG94602026-08-03
10888277417212MEDLINEMSG9465MSG94652026-08-03
10888277417229MEDLINEMSG9470MSG94702026-08-03
10888277417236MEDLINEMSG9475MSG94752026-08-03
10888277417243MEDLINEMSG9480MSG94802026-08-03
10888277417250MEDLINEMSG9485MSG94852026-08-03
10888277417267MEDLINEMSG9490MSG94902026-08-03
10888277603516MEDLINEMSG9590MSG95902026-08-03
20197344102898GeminiGEM3120CGEM3120C2024-08-02
20197344102904GeminiGEM3120SCGEM3120SC2024-07-15
10080196184125GeminiGEM3120SGEM3120S2016-10-14
10080196184286MEDLINEGEM3130SGEM3130S2016-10-14
10197344169405MEDLINEMSCSRG9636MSCSRG96362026-07-31
10198459678653MEDLINEURO175806PSURO175806PS2026-07-31
10198459678660MEDLINEURO175808PSURO175808PS2026-07-31
10198459678677MEDLINEURO175806SURO175806S2026-07-31
10198459678684MEDLINEURO175808SURO175808S2026-07-31
10198459678691MEDLINEURO175810SURO175810S2026-07-31
10198459679025MEDLINEURO175810PSURO175810PS2026-07-31
20197344219237MEDLINENON27393NON273932026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528464HalyardAVID MEDICAL, INC.OEZ2026-08-03
10809160528563HalyardAVID MEDICAL, INC.OEZ2026-08-03
10809160528600HalyardAVID MEDICAL, INC.OEZ2026-08-03
00884450447093Merit Medical®Merit Medical Systems, Inc.OEZ2026-08-01
10197106933145CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956027596CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956421615CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956439177CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956464292CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956491663CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956500235CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956512856CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956513020CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956523746CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956533059CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956534162CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956535954CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536203CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536234CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536418CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956536937CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538443CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538528CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538740CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956538764CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956539112CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956539150CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956539464CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956541146CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31
10198956541313CARDINAL HEALTHCardinal Health 200, LLCOEZ2026-07-31