FDA.report

Medline Industries, Inc.

Primary DI
40195327390885
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYND150518
Catalog number
DYND150518
Device description
TRAY FOLEY SILVER 18FR 10ML UM
Published
2023-05-07
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

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
40195327390885PackageGS110In Commercial Distribution
10195327390884PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4019532739088540195327390885
1019532739088410195327390884

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
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
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
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 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
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50197106726523CARDINAL HEALTHCardinal Health 200, LLCPPB2024-09-03
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40195327165018Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
40195327396504Medline Industries, Inc.MEDLINE INDUSTRIES, INC.PPB2023-05-14
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