Tension Pneumothorax Kit w/ Capnospot

Primary DI
00818630016328
Brand
Tension Pneumothorax Kit w/ Capnospot
Company
TACTICAL MEDICAL SOLUTIONS, LLC
Model
A
Device description
The Advanced Tension Pneumothorax Kit from TacMed Solutions™ provides for state-of-the-art placement of needle thoracostomy using evidence-based equipment for surface anatomy, durable and reliable decompression, and decompression indicators more accurate than current standard of care auditory assessments. The Advanced kit features Capnospot® which lets you know you're in by offering objective, visual confirmation.
Published
2025-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818630016328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818630016328008186300163288186300163280818630016328

GMDN Terms#

Term, Definition table
TermDefinition
Pneumothorax catheter insertion setA collection of devices used to puncture the chest wall to enable insertion of a dedicated catheter for the aspiration of a simple pneumothorax or decompression of a tension pneumothorax. It typically consists of a scalpel to make a stab incision and a needle to assist the entry of the catheter with obturator assembly (to protect the internal organs upon entry). Once the catheter is in place, the needle is retracted to allow the flow of air/fluid from within the chest cavity. The set may contain suture for the attachment of the catheter to the skin. It is typically used for accident and emergency (A&E) situations (immediate care or chest crush injury). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
131480662
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00818630014515Foxtrot Litter with Red CarrierAF-LITC-R2020-10-21
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