Nexa Foam

GUDID 15060826400066

Single piece of foam used in Nexa Dressing.

NEXA MEDICAL LIMITED

Negative-pressure wound therapy system foam dressing, non-antimicrobial
Primary Device ID15060826400066
NIH Device Record Key541bb054-1f67-420f-aae0-89d427d2e6e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexa Foam
Version Model Number414-00-701
Company DUNS221046947
Company NameNEXA MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115060826400066 [Package]
Contains: 25060826400063
Package: Box [5 Units]
In Commercial Distribution
GS125060826400063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-07
Device Publish Date2023-08-30

Devices Manufactured by NEXA MEDICAL LIMITED

15060826400004 - NEXA NPWT Device Kit2023-09-07 Nexa NPWT Device kit containing Nexa NPWT Device, Charger and carry case
15060826400059 - NEXA Drape2023-09-07 Single drape pieces
15060826400066 - Nexa Foam2023-09-07Single piece of foam used in Nexa Dressing.
15060826400066 - Nexa Foam2023-09-07 Single piece of foam used in Nexa Dressing.
15060826400011 - NEXA NPWT DRESSING -125mmHg2023-09-07 Nexa NPWT dressing -125mmHg pressure level. To be used in conjunction with Nexa Device and Nexa Fluid Container Pack
15060826400035 - NEXA NPWT FLUID CONTAINER PACK2023-09-07 Nexa NPWT Fluid Container Pack is used as a disposable receptacle for wound fluid.

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