FDA.reportPublic FDA data

SCOOP

Primary DI
B181C1320
Brand
SCOOP
Company
TRANSTRACHEAL SYSTEMS, INC.
Model
C-13-2
Catalog number
C-13-2
Device description
Transtracheal Catheters and Cleaning Rods (Two Pack) 13cm
Published
2020-09-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTOTube, Tracheostomy (W/Wo Connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B181C1320PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration transtracheal catheterA flexible tube intended to be introduced across the tracheal wall to provide supplementary oxygen (O2) to the respiratory tract of a person who is unable to breathe through the nose or mouth because of obstruction. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
826282220
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B181C110SCOOPC-11C-112020-10-07
B181C1120SCOOPC-11-2C-11-22020-10-07
B181C11HF20SCOOPC-11HF-2C-11HF-22020-10-07
B181C90SCOOPC-9C-92020-10-07
B181C920SCOOPC-9-2C-9-22020-10-07
B181C9HF20SCOOPC-9HF-2C-9HF-22020-10-07
B181C130SCOOPC-13C-132020-09-16
B181C13HF20SCOOPC-13HF-2C-13HF-22020-09-16

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Primary DI, Brand, Company table
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