FDA.reportPublic FDA data

Medline

Primary DI
40080196966210
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYNJWE1305
Catalog number
DYNJWE1305
Device description
RESERVOIR,SUCTION,100CC,SILICONE
Published
2023-09-14
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196966210PackageGS110In Commercial Distribution
10080196966219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019696621040080196966210
1008019696621910080196966219

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 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
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10848530106994Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-08-14
10848530107007Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-08-14
10848530107014Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-08-14
00848530107185Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-08-12
40817640021757Tru-Close Suction Drainage SystemURESIL, LLCGCY2025-08-05
40817640021764Tru-Close Suction Drainage SystemURESIL, LLCGCY2025-08-05
10848530106161Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-07-02
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10848530106185Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-07-02
10848530095229Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-06-03
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10848530106277Tracheostomy and Suction AccessorySUNSET HEALTHCARE SOLUTIONS, INC.GCY2025-06-03
00860013965303Cobb-XLR Excellerator™5TH INTERVAL MEDICAL LLCGCY2025-05-05
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50198956012767CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
09420060206012Silicone Penguin Nasal AspiratorTHINK GREEN LIMITEDGCY2024-12-17
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10840306831048Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
10840306836081Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
10840306836098Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.GCY2024-12-12
00817640021704Tru-Close Suction Drainage SystemURESIL, LLCGCY2024-11-11