DART-Reach

GUDID 10841470103801

ENGINEERED MEDICAL SYSTEMS INC

Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory Atomizer, non-ventilatory
Primary Device ID10841470103801
NIH Device Record Keybc116a6e-c321-434b-94f5-77b22008416f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDART-Reach
Version Model Number301-REACH600
Company DUNS154502934
Company NameENGINEERED MEDICAL SYSTEMS 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
GS100841470103804 [Primary]
GS110841470103801 [Package]
Contains: 00841470103804
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]

10841470103825301-REACH700
10841470103818301-REACH720
10841470103801301-REACH600

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