Foam Kit Thin Large

GUDID 00849405021230

The Genadyne Foam Kit Thin Large consists of a XLR8 Port, two XLR8 Transparent Film and a Foam T Large. Each component is packaged, sealed and sterilized individually and then bagged into a kit.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system foam dressing
Primary Device ID00849405021230
NIH Device Record Key8ee6a327-163f-45a2-84fe-9ef55f0ba601
Commercial Distribution StatusIn Commercial Distribution
Brand NameFoam Kit Thin Large
Version Model NumberXF-DLGF1-T
Company DUNS006616130
Company NameGENADYNE BIOTECHNOLOGIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849405021230 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by GENADYNE BIOTECHNOLOGIES INC.

00849405000013 - XLR8 Transparent Film Dressing2023-12-27 Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm.
00849405001454 - XLR8/XLR8+ Port2023-12-27 Medical grade suction port that has a PU film with acrylic adhesive attached to it.
00849405000389 - UNO Plus 200 CC Collection Canister2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes:
00849405000488 - UNO Plus 300 CC Collection Canister2023-06-21 All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes:
00849405000495 - UNO Plus Negative Pressure Wound Therapy Device2023-06-21 The Genadyne UNO+ NPWT (Ref # UP-S01) is a multi-patient use, rechargeable Negative Pressure Wound Therapy unit, designed for mo
00849405000525 - UNO 10x10 Dressing kit2023-06-19 The UNO Dressing is constructed with 4 different layers. The top layer is a polyurethane material, where the suction port is att
00849405000532 - UNO 15 Therapy Kit 10x102023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The
00849405000549 - UNO 7 Therapy Kit 10x102023-06-19 The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The

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