FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40195327473762
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJ85190
Catalog number
DYNJ85190
Device description
OR ANGIO PACK
Published
2023-08-06
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
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40195327473762PackageGS13In Commercial Distribution
10195327473761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019532747376240195327473762
1019532747376110195327473761

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463customerservice@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
10080196726707Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2024-12-22
10193489016390Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-12-21
10193489067231Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-12-21
10193489439298Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-07-29
10193489455601Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-13
10193489409987Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489414059Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489414073Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489416046Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489416169Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489417197Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489418903Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421125Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421286Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421682Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421699Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489421910Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489423273Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489425413Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489425871Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426168Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426182Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489426502Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489427752Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489428865Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489430158Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489430691Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489431384Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489432916Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08
10193489434293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OES2023-06-08