FDA.reportPublic FDA data

LMA ATOMIZATION

Primary DI
24026704717532
Brand
LMA ATOMIZATION
Company
TELEFLEX INCORPORATED
Model
IPN056585
Catalog number
AMG600SU
Device description
MADgic Atomizer with 3 mL Syringe
Published
2020-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
K153470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153470000MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical2016-08-19CCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704717532PackageGS125In Commercial Distribution
34026704717539PackageGS14In Commercial Distribution
14026704717535PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670471753224026704717532
3402670471753934026704717539
1402670471753514026704717535

GMDN Terms#

Term, Definition table
TermDefinition
Laryngotracheal anaesthesia applicatorA non-sterile container (e.g., a spray bottle) that is prefilled with an anaesthetic agent and intended to be used to apply the agent to the oropharynx and upper airway, to relax laryngotracheal reflexes prior to an intervention [typically insertion of an endotracheal (ET) tube or other type of tracheal tube]. It is typically used on non-pharmacologically paralyzed patients where multiple reflexes (e.g., the gag reflex, glottic closure, vocal cord spasm, cough reflex, and bronchoconstriction) could make difficult or inhibit safe intervention. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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
00841470100315DART-ReachPULMODYNE INCCCT2022-03-25
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
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