FDA.reportPublic FDA data

MEDLINE

Primary DI
10193489198256
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
DYNDA2544
Catalog number
DYNDA2544
Device description
3WAY LF CATHETER KIT
Published
2020-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCNUrinary drainage collection kit, for indwelling catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCNUrinary Drainage Collection Kit, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20193489198253PackageGS120In Commercial Distribution
10193489198256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019348919825320193489198253
1019348919825610193489198256

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11
10812564036381MedlineSYN3872SYN38722026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063139403Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139410Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139427Neil Medical Group Neil Medical GroupFCN2025-12-08
10192253051629DoverCardinal Health 200, LLCFCN2025-11-07
00661392002388LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
00661392025646LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
10840330701751ProCureTwin Med, LLCFCN2025-05-31
10840330701768ProCureTwin Med, LLCFCN2025-05-31
10840330701775ProCureTwin Med, LLCFCN2025-05-31
10840330701782ProCureTwin Med, LLCFCN2025-05-31
30840330701755ProCureTwin Med, LLCFCN2025-05-31
30840330701762ProCureTwin Med, LLCFCN2025-05-31
30840330701779ProCureTwin Med, LLCFCN2025-05-31
30840330701786ProCureTwin Med, LLCFCN2025-05-31
00850058254791TruCathHR PHARMACEUTICALS INC.FCN2025-01-16
10192253027686DoverCardinal Health 200, LLCFCN2024-10-14
50192253027684DoverCardinal Health 200, LLCFCN2024-10-14
10192253065480DoverCardinal Health 200, LLCFCN2024-09-03
10192253065497DoverCardinal Health 200, LLCFCN2024-09-03
10192253065619DoverCardinal Health 200, LLCFCN2024-09-03
10192253065626DoverCardinal Health 200, LLCFCN2024-09-03
50192253065488DoverCardinal Health 200, LLCFCN2024-09-03
50192253065495DoverCardinal Health 200, LLCFCN2024-09-03
50192253065617DoverCardinal Health 200, LLCFCN2024-09-03
50192253065624DoverCardinal Health 200, LLCFCN2024-09-03
10192253051612DoverCardinal Health 200, LLCFCN2024-08-08
50192253051610DoverCardinal Health 200, LLCFCN2024-08-08
10850053289085SURGYCOSurgyco LLCFCN2023-12-15
10850053289092SURGYCOSurgyco LLCFCN2023-12-15
10850053289108SURGYCOSurgyco LLCFCN2023-12-15