FDA.reportPublic FDA data

MEDLINE

Primary DI
00653160376586
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC2787A
Catalog number
DYNDC2787A
Device description
DIALYSIS ON CUSTOM KIT
Published
2024-06-26
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
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
00653160376586PackageGS150In Commercial Distribution
10653160376583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653160376586006531603765866531603765860653160376586
1065316037658310653160376583

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.

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
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956094725CARDINAL HEALTHCardinal Health 200, LLCFKG2025-06-10
50197106986491CARDINAL HEALTHCardinal Health 200, LLCFKG2025-03-21
00653160378689MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-08-05
00653160375176MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-05-28
00653160373585MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-04-25
20809160422684Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.FKG2024-03-28
00653160372403MEDLINEMEDLINE INDUSTRIES, INC.FKG2024-03-15
50197106349869CARDINAL HEALTHCardinal Health 200, LLCFKG2023-09-29
50197106347186CARDINAL HEALTHCardinal Health 200, LLCFKG2023-07-25
00653160361001MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-06-16
50197106092451CARDINAL HEALTHCardinal Health 200, LLCFKG2023-06-09
00653160359633MEDLINEMEDLINE INDUSTRIES, INC.FKG2023-04-28
50197106230990CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-25
50197106200290CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
50197106212651CARDINAL HEALTHCardinal Health 200, LLCFKG2023-04-18
00653160359541CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2023-04-14
50197106198429CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-30
50197106174294CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-29
50197106156009CARDINAL HEALTHCardinal Health 200, LLCFKG2023-03-03
50197106136537CARDINAL HEALTHCardinal Health 200, LLCFKG2023-02-23
50197106043323CARDINAL HEALTHCardinal Health 200, LLCFKG2022-12-05
00653160356076CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2022-11-15
00653160356816MEDLINEMEDLINE INDUSTRIES, INC.FKG2022-11-15
00653160356267CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFKG2022-11-08
50195594678768CARDINAL HEALTHCardinal Health 200, LLCFKG2022-10-11
50195594780577CARDINAL HEALTHCardinal Health 200, LLCFKG2022-08-19
50195594756831CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594758521CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
50195594767189CARDINAL HEALTHCardinal Health 200, LLCFKG2022-07-29
00653160353785MEDLINEMEDLINE INDUSTRIES, INC.FKG2022-07-01