FDA.reportPublic FDA data

MEDLINE

Primary DI
10653160375173
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC2786A
Catalog number
DYNDC2786A
Device description
DIALYSIS OFF CUSTOM KIT
Published
2024-05-28
Public version status
New
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
FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FKGTray, Start/Stop (Including Contents), DialysisGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00653160375176PackageGS150In Commercial Distribution
10653160375173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160375176006531603751766531603751760653160375176
1065316037517310653160375173

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis start/stop setA collection of instruments and associated items used for the start and/or stop procedures (also known as ON and OFF procedures) for a patient undergoing haemodialysis. It typically includes items such as syringes, needles, dressings, swabs, forceps, and protective wear for the healthcare provider such as gloves, face mask, and a gown. This device is used for the connection session and/or the disconnection session where the patient is connected/disconnected to the haemodialysis system. It does not include pharmaceuticals and typically does not include catheters. This is a single-use device.

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
Combination product
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
30197344020779MEDLINEDYND364951DYND3649512026-08-19
00080196549422MEDLINE486800PL486800PL2025-05-06
00197344024936MEDLINEMG5002MG50022024-03-13
00888277172015MEDLINESG310SG3102024-05-02
00888277327552MEDLINE486802PL486802PL2025-03-25
00888277327569MEDLINE486803PL486803PL2025-03-25
00888277327576MEDLINE486804PL486804PL2025-03-25
00888277415075MEDLINE486801PL486801PL2025-05-06
40080196294344MEDLINEMDR107003LMDR107003L2020-10-12
40080196320999MEDLINEMDR107002EMDR107002E2016-10-14
40080196321002MEDLINEMDR107003EMDR107003E2016-10-14
10889942000388NAMICDYNJCAPDYNJCAP2026-08-18
10889942000395NAMICDYNJCAPRDYNJCAPR2026-08-18
20197344158895MEDLINEMDT12080XLMDT12080XL2026-08-18
20197344158918MEDLINEMDT12081LMDT12081L2026-08-18
20197344158932MEDLINEMDT12083LMDT12083L2026-08-18
20197344158956MEDLINEMDT12083XLMDT12083XL2026-08-18
20197344158970MEDLINEMDT12084XLMDT12084XL2026-08-18
20197344158987MEDLINEMDT12085LMDT12085L2026-08-18
20197344159014MEDLINEMDT12086XLMDT12086XL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956504134CARDINAL HEALTHCardinal Health 200, LLCFKG2026-07-09
10198956441064CARDINAL HEALTHCardinal Health 200, LLCFKG2026-05-08
10198956094727CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
10197106986493CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
50197106986491CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
10653160378686MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
00653160378689MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
10653160376583MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
00653160376586MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-06-26
00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
10653160373582MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
10809160422687Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
10653160372400MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
10197106349861CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
10197106347188CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
10653160361008MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
10197106092453CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
10653160359630MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
10197106230992CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
10197106200292CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18