UNO NPWT 70CC Collection Canister

GUDID 00849405001058

The UNO Canister comes in only 1 size, which is 70cc. It has a solidifier gel sheet inside to solidify any collected exudates. The canister is made out of ABS plastic material. At the suction interface, where it is connected to the UNO pump, there is a hydrophobic filter welded to it. The filter has a 0.2 micron pore size, which has a bacteria filtration efficiency (BFE) of over 99%. The UNO canister is a disposable single use item. It comes packaged in a medical grade paper pouch.

GENADYNE BIOTECHNOLOGIES INC.

Negative-pressure wound therapy system canister
Primary Device ID00849405001058
NIH Device Record Key3e3e7c32-0637-4be0-b1a7-7f541b3d8955
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNO NPWT 70CC Collection Canister
Version Model NumberU-C070
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 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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100849405001058 [Primary]

FDA Product Code

OMPNegative Pressure Wound Therapy Powered Suction Pump

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00849405001058]

Ethylene Oxide


[00849405001058]

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[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


[00849405001058]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

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