FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489191004
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DT22365
Catalog number
DT22365
Device description
DIALYSIS ON OFF KIT
Published
2020-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
20193489191001PackageGS125In Commercial Distribution
10193489191004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919100120193489191001
1019348919100410193489191004

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
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
10080196180639GeminiGEM1115SGEM1115S2020-12-22
00080196749884MEDLINEMDS149010MDS1490102024-03-05
00080196749891MEDLINEMDS149000MDS1490002021-09-09
10080196418329MEDLINEHCS4482RHCS4482R2021-03-31
10080196418336MEDLINEHCS4483RHCS4483R2020-12-01
10080196715534HUDSON RCIHCS4482HCS44822021-03-31
10080196715565MEDLINEHCS4486HCS44862021-03-31
10888277657625MEDLINEHCSU4483HCSU44832021-10-01
10888277699205MEDLINEHCS4481VTHCS4481VT2021-10-01
10888277699229MEDLINEHCS4483VTHCS4483VT2021-10-01
10888277699236MEDLINE INDUSTRIESHCSU448314HCSU4483142021-10-01
00888277692100MEDLINEHCS4480HCS44802021-05-18
00888277699215MEDLINEHCS448314HCS4483142021-05-18
10080196715541MEDLINEHCS4483HCS44832020-10-28
00888277682033MEDLINEHCSU4482HCSU44822020-08-21
00888277682040MEDLINEHCSU4485HCSU44852020-08-21
10080196259441MedlineMDT013380MDT0133802016-10-14
10080196993819MEDLINEDYND19120DYND191202020-11-12
00080196515939CURADCUR9224CUR92242026-07-06
10197344012039HUDSON RCIHUD1743HUD17432026-07-06

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
10653160375173MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
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