FDA.reportPublic FDA data

Durma+ Y-Type Suction Drainage Tube, 10 Fr

Primary DI
00840117345539
Brand
Durma+ Y-Type Suction Drainage Tube, 10 Fr
Company
Dynarex Corporation
Model
3147
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162159000VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC2017-04-28OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117345522PackageGS120In Commercial Distribution
00840117345539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117345522008401173455228401173455220840117345522
00840117345539008401173455398401173455390840117345539

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system canisterA receptacle for the collection of excess interstitial fluid, exudate, and infectious materials from a dedicated dressing that has been applied for a vacuum-assisted wound closure procedure; commonly known as negative pressure wound therapy (NPWT). It is typically made of transparent disposable plastic materials and is connected to or placed into the NPWT system's vacuum pump. This receptacle is a single-use device that should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

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00840117352339Hypodermic Needle, Non-Safety, 20G, 3/4" needles69802019-05-06
00616784910017CurPro Nylon Suture, Black Monofilament, Nonabsorbable, Synthetic91002016-09-24
00616784910116CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91012016-09-24
00616784910215CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91022016-09-24
00616784910314CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91032016-09-24
00616784910413CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91042016-09-24
00616784910611CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91062016-09-24
00616784910710CurPro Nylon Sutures, Black Monofilament, Nonabsorbable, Synthetic91072016-09-24
00616784913018Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet, Braided91302016-09-24
00616784913117CurPro Polyglycolic Acid (PGA) Sutures, Coated Synthetic Absorbable, Violet91312016-09-24
00616784914213CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91422016-09-24
00616784914312CurPro Silk Sutures Natural Material, Braided Black, Nonabsorbable91432016-09-24
00840117325920Bari + Max Bariatric Steel Crutches, Tall Adult, 1000 lb. weight capacity,101052023-01-11
00840117325937Bari + Max Bariatric Steel Crutches, Adult, 1000 lb. Weight Capacity, 1 Pair101062023-01-11
00616784010113Aluminum Crutches - Youth101012019-09-30
00616784010212Aluminum Crutches - Adult101022019-09-30
00616784010311Aluminum Crutches - Tall101032019-09-30
00616784010410DMECARE Solutions, Universal Crutches101042019-09-26
00840117352124AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67212019-11-25
00840117352148AloeSkin, Nitrile Examination Gloves, With Vitamin E, Powder-Free, Rose Gloves67222019-11-25

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