FDA.report

Medline

Primary DI
40080196030874
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND12200
Catalog number
DYND12200
Device description
PLUG,CATHETER,DRAINAGE PROTECTOR,TUBE
Published
2016-10-14
Public version status
Update
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
GCDCONNECTOR, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
40080196030874PackageGS1100In Commercial Distribution
10080196030873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
4008019603087440080196030874
1008019603087310080196030873

GMDN Terms

TermDefinition
Suprapubic drainage catheterA flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a patient for the drainage of urine; it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube with holes/tips at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion; however, it does not include non-dedicated supportive devices (i.e., not a kit). This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temp/Avoid excessive heat, Do Not Freeze

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
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
50749756399147DeRoyalDEROYAL INDUSTRIES, INC.GCD2025-06-19
24026704911855PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-04-29
50192253042908ArgyleCardinal Health 200, LLCGCD2025-03-07
50192253042830ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042854ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042861ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042878ArgyleCardinal Health 200, LLCGCD2025-02-27
50192253042885ArgyleCardinal Health 200, LLCGCD2025-02-27
24026704933123PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933130PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933147PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
24026704933154PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
07540198003016FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
07540198003115FlexTubePrime Pacific Health Innovations CorporationGCD2023-10-27
04710961934967Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934974Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934981Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961934998Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935001Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935018Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935025Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935032Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935049Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935056Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935063Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935070Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935087Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935094Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935100Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
04710961935117Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31