FDA.report

Medline Industries, Inc.

Primary DI
40193489860451
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDC3084
Catalog number
DYNDC3084
Device description
DIALYSIS KIT
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FKGTRAY, START/STOP (INCLUDING CONTENTS), DIALYSIS

Product Code Classifications

CodeDeviceSpecialtyClass
FKGTray, Start/Stop (Including Contents), DialysisGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40193489860451PackageGS125In Commercial Distribution
10193489860450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019348986045140193489860451
1019348986045010193489860450

GMDN Terms

TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods

Method

Contacts

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
false
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

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Other Devices Sharing Product Codes

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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
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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