DART-Reach

GUDID 10841470100329

PULMODYNE INC

Atomizer, non-ventilatory
Primary Device ID10841470100329
NIH Device Record Keya9fb9acf-cc17-4f8e-af28-1e265dedf169
Commercial Distribution StatusIn Commercial Distribution
Brand NameDART-Reach
Version Model NumberREACH700
Company DUNS030619483
Company NamePULMODYNE 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter
Length218 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100841470100322 [Primary]
GS110841470100329 [Package]
Contains: 00841470100322
Package: [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCTApplicator (Laryngo-Tracheal), Topical Anesthesia

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-25

On-Brand Devices [DART-Reach]

10841470100336REACH720
10841470100329REACH700
10841470100312REACH600

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