FDA.reportPublic FDA data

Medline Industries, Inc.

Primary DI
40888277804846
Brand
Medline Industries, Inc.
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJZ80914
Catalog number
DYNJZ80914
Device description
TBG TUR IRRIG Y-TYPE 90IN
Published
2023-07-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQOCatheter, intravascular, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277804846PackageGS120In Commercial Distribution
10888277804845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827780484640888277804846
1088827780484510888277804845

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
false
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
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10884450787080Impress®Merit Medical Systems, Inc.DQO2026-03-19
50690103218607SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
10884450710729Impress®Merit Medical Systems, Inc.DQO2026-03-11
20841156111486LANGSTONTELEFLEX INCORPORATEDDQO2026-03-11
10884450787103Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450787455Impress®Merit Medical Systems, Inc.DQO2026-03-03
10884450788070Impress®Merit Medical Systems, Inc.DQO2026-02-19
10884450787653Impress®Merit Medical Systems, Inc.DQO2026-02-14
10884450852849Impress®Merit Medical Systems, Inc.DQO2026-02-14
50690103000417SWAN-GANZEdwards Lifesciences LLCDQO2026-01-30
00884450722329Impress®Merit Medical Systems, Inc.DQO2026-01-28
10884450787516Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450788124Impress®Merit Medical Systems, Inc.DQO2026-01-23
10884450787059Impress®Merit Medical Systems, Inc.DQO2026-01-22
10884450787837Impress®Merit Medical Systems, Inc.DQO2026-01-22
04987350744487DUALVIEWTERUMO CORPORATIONDQO2026-01-21
10884450787271Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787530Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450788797Impress®Merit Medical Systems, Inc.DQO2026-01-16
10884450787721Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787745Impress®Merit Medical Systems, Inc.DQO2026-01-13
10884450787707Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450787752Impress®Merit Medical Systems, Inc.DQO2026-01-03
10884450835934Performa®Merit Medical Systems, Inc.DQO2026-01-03
10884450787813Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787820Impress®Merit Medical Systems, Inc.DQO2025-12-24
10884450787547Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450788650Impress®Merit Medical Systems, Inc.DQO2025-12-23
10884450787387Impress®Merit Medical Systems, Inc.DQO2025-12-20