FDA.reportPublic FDA data

Typenex Wound Drainage

Primary DI
00851878008571
Brand
Typenex Wound Drainage
Company
TYPENEX MEDICAL LLC
Model
WD0401K1
Device description
7 mm Flat Perforated, Full Kit with 100 cc Evacuator
Published
2022-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBXCatheter, Irrigation
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBXCatheter, IrrigationGeneral, Plastic Surgery1
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851878008571PackageGS110In Commercial Distribution
00851878008564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851878008571008518780085718518780085710851878008571
00851878008564008518780085648518780085640851878008564

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainage kitA collection of devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors, a grasping device and possibly a trocar for placing the drains/catheters into the site. The reservoir will usually be provided with graduated markers along its side to facilitate the approximate measurement of the collected fluids. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600850213
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20810050855833Microscope SlidesLC0105B2026-03-23
B050SL1000021Sterile LabelsSL-1000022026-03-17
00810050855815ThermoFlo®60612026-01-26
10810050855805Typenex Introducer SetMS2335S2025-11-17
10810050855782Fibernex Laser SystemLS02012025-07-28
20810050855772Microscope SlidesLC0104B2025-07-14
20810050855765Microscope SlidesPS0204W2025-07-08
20810050855741Microscope SlidesPS0404WXT2025-06-17
20810050855758Microscope SlidesPS0404YXT2025-06-17
00810050855457Rad ControlRT03022025-05-23
00810050855471Rad ControlRT03012025-05-23
20810050855697Microscope SldiesLC01012025-02-03
20810050855703Microscope SlidesLC02032025-02-03
20810050855710Microscope SlidesLC01042025-02-03
20810050855727Microscope Slides LC01032025-02-03
20810050855734Microscope SlidesPS0202WXL2025-02-03
20810050855680Microscope SlidesPS0404W2025-01-21
00810050855631ThermoFlo®62412024-12-06
10810050855669ThermoFlo®60012024-11-20
20810050855673Microscope SlidesPS0201WXL2024-11-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KGZ2026-02-26
00822045001503SAM ThoraSite®SAM Medical ProductsGBX2025-12-12
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
20885380182430JACKSON-PRATTCardinal Health 200, LLCGBX2025-09-12
20885380182508CARDINAL HEALTHCardinal Health 200, LLCGBX2025-09-12
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
34026704933373PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-08
34026704933380PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
24026704933406PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-07-02
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10884450581008ReSolve®Merit Medical Systems, Inc.GBX2025-05-23
10661392032009LSL HEALTHCARELSL Industries, LLCGBX2025-05-16
10884450779900ReSolve®Merit Medical Systems, Inc.GBX2025-05-13
00840456205891JMUJMU DENTAL, INCGBX2025-05-02
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
24026704933345PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933352PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933413PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-04-04
24026704933468PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933472PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933489PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
24026704933499PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933502PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933519PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
34026704933526PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-27
05708932767811SopranoColoplast A/SKGZ2025-03-26
34026704933311PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
34026704933328PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26
24026704933338PLEUR-EVACTELEFLEX INCORPORATEDGBX2025-03-26