FDA.report

Medline Industries, Inc.

Primary DI
40195327087976
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYKE1672A
Catalog number
DYKE1672A
Device description
UNIVERSAL ENDO PROCEDURE PACK
Published
2022-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
PPBFoley catheter kit (excludes HIV testing)

Product Code Classifications

CodeDeviceSpecialtyClass
PPBFoley Catheter Kit (Excludes Hiv Testing)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40195327087976PackageGS118In Commercial Distribution
10195327087975PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019532708797640195327087976
1019532708797510195327087975

GMDN Terms

TermDefinition
General/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10080196163885MEDLINENONTH100BNONTH100B2026-03-24
10884389110003MEDLINECRI5001BCRI5001B2026-03-24
10884389110010MEDLINECRI5000BCRI5000B2026-03-24
10884389110072MEDLINENONTH200BNONTH200B2026-03-24
30193489036224MEDLINEMDSE2RDCAMDSE2RDCA2022-12-10
30193489036248MEDLINEMDSE2RDCPMDSE2RDCP2022-12-10
30193489036262MEDLINEMDSE2X2CAMDSE2X2CA2022-12-10
40888277170897MEDLINEFG1501FG15012026-03-20
40888277170972MEDLINEFG1503FG15032026-03-20
40888277358455MEDLINEMPHPN315MPHPN3152026-03-19
40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253068199DoverCardinal Health 200, LLCPPB2026-01-15
50192253068205DoverCardinal Health 200, LLCPPB2026-01-15
40198459403096MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PPB2025-07-21
40198459407087MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.PPB2025-07-07
40198459290320Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2025-03-16
40198459277710Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2025-03-02
50192253030523DoverCardinal Health 200, LLCPPB2024-12-20
50192253030530DoverCardinal Health 200, LLCPPB2024-12-20
10195327537319Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-11-03
10195327537326Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-11-03
40195327537334Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-11-03
50197106726523CARDINAL HEALTHCardinal Health 200, LLCPPB2024-09-03
40195327043071Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2024-06-30
10195327498344Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-09-17
40195327444816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-08-06
40195327341863Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-13
40193489987127Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489987134Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988360Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988377Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988384Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988520Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988612Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988629Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988636Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988889Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40193489988896Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-06-08
40195327165018Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
40195327396504Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
40195327396528Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14