Portable Negative Pressure Vacuum

GUDID 00860008240125

Robrady Inc

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Primary Device ID00860008240125
NIH Device Record Keyee19e45f-8b04-4a1f-b0d7-2f4334ba7c2a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePortable Negative Pressure Vacuum
Version Model NumberSFER-0V-1001
Company DUNS064578649
Company NameRobrady Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008240125 [Primary]

FDA Product Code

FZIApparatus, Air Handling, Enclosure

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-17
Device Publish Date2022-02-09

Devices Manufactured by Robrady Inc

00860008240101 - EndoShield2022-02-17
00860008240118 - Respiratory Shield2022-02-17
00860008240125 - Portable Negative Pressure Vacuum2022-02-17
00860008240125 - Portable Negative Pressure Vacuum2022-02-17

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