FDA.reportPublic FDA data

DART-Reach

Primary DI
00841470100315
Brand
DART-Reach
Company
PULMODYNE INC
Model
REACH600
Published
2022-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCTApplicator (Laryngo-Tracheal), Topical Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCTApplicator (Laryngo-Tracheal), Topical AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070596000TOPICAL APPLICATORSharn, Inc.2007-06-21CCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470100312PackageGS125In Commercial Distribution
00841470100315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147010031210841470100312
00841470100315008414701003158414701003150841470100315

GMDN Terms#

Term, Definition table
TermDefinition
Atomizer, non-ventilatory A non-powered, non-ventilatory device intended to provide liquid medication in an aerosolized airborne form for a patient to breathe. It is typically hand-operated. Unlike a nebulizer this devices lacks a baffle, therefore the particle size of the aerosol is not stabilized.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length218Millimeter

Regulatory Flags#

DUNS number
030619483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470100841Percussor313-41962026-05-29
00841470100858Percussor313-41972026-05-29
00841470104740BiTrac Select313-95892025-09-30
00841470104764BiTrac Select313-95912025-09-30
00841470100148O2-MAX313-8201-62025-04-12
00841470105501BiTrac101615782025-04-11
00841470105518BiTrac 101615772025-04-11
00841470105525BiTrac101615792025-04-11
00841470105532BiTrac101615762025-04-11
00841470105549BiTrac 101600492025-04-11
00841470105556BiTrac 101600502025-04-11
00841470105563BiTrac 101600512025-04-11
00841470105570BiTrac 101600522025-04-11
00841470105587BiTrac SE101600532025-04-11
00841470105594BiTrac SE101600542025-04-11
00841470105600BiTrac SE101600552025-04-11
00841470105617BiTrac SE101600562025-04-11
00841470105631BiTrac Select101617662025-04-11
00841470105648BiTrac Select101617672025-04-11
00841470105655BiTrac Select101617682025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704709868LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
14026704709875LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
14026704709882LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
34026704709862LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
24026704709872LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
24026704709889LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2023-08-31
00841470100322DART-ReachPULMODYNE INCCCT2022-03-25
00841470100339DART-ReachPULMODYNE INCCCT2022-03-25
00841470103804DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
00841470103811DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
00841470103828DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
10841470100312DART-ReachPULMODYNE INCCCT2022-03-25
10841470100329DART-ReachPULMODYNE INCCCT2022-03-25
10841470100336DART-ReachPULMODYNE INCCCT2022-03-25
10841470103801DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
10841470103818DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
10841470103825DART-ReachENGINEERED MEDICAL SYSTEMS INCCCT2022-03-25
14026704717535LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
14026704717542LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
14026704717559LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
24026704717532LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
34026704717546LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
34026704717553LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2020-07-30
00815277029407CuraplexBOUND TREE MEDICAL, LLCCCT2018-12-15
00817617029924CuraplexBOUND TREE MEDICAL, LLCCCT2018-12-15
00817617028842CuraplexBOUND TREE MEDICAL, LLCCCT2017-12-12
14026704613219LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-10-27
34026704613213LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-10-27
14026704613196LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-09-25
14026704613226LMA ATOMIZATIONTELEFLEX INCORPORATEDCCT2017-09-25