NOxBOXi NOXKIT 2-12 LGENOXKIT-2-12

GUDID 00850046301056

NOxBOXi NOXKIT 2-12 Patient Kit for use with the NOxBOXi nitric oxide delivery device.

Linde Gas & Equipment Inc.

Nitric oxide delivery unit, system-based
Primary Device ID00850046301056
NIH Device Record Key2bce4de6-7d94-4316-8238-d2b40e2d13d0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOxBOXi NOXKIT 2-12
Version Model Number1
Catalog NumberLGENOXKIT-2-12
Company DUNS042845636
Company NameLinde Gas & Equipment 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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850046301049 [Primary]
GS100850046301056 [Package]
Contains: 00850046301049
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

MRPAnalyzer, Nitric Oxide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

Devices Manufactured by Linde Gas & Equipment Inc.

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