FDA.reportPublic FDA data

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

Other Devices From This Company#

Primary DI, Brand, Model table
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00818630019053BRIDGE™ FRIDGE RefrigeratorA1041262026-05-05
00818630019008Expeditionary Refrigerator (xFRIDGE™)A1039872026-04-24
00860015036803Expeditionary RefrigeratorA2026-01-07
00199284492608TacMed™ Vascular Access KitAVAK2025-04-29
00818630010456HELIOS SystemAHELIOS-K2025-03-26
00818630010463HELIOS SystemAHELIOS-KW2025-03-26
00818630010524Foxtrot Litter with ACU CarrierAF-LITC-A2020-10-21
00818630010531Foxtrot Litter with Black CarrierAF-LITC-B2020-10-21
00818630010555Foxtrot Litter with Tan CarrierAF-LITC-T2020-10-21
00818630010562Foxtrot Litter DA, with ACU CarrierAF-LITC-DA-A2020-10-21
00818630010579Foxtrot Litter DA, with Black CarrierAF-LITC-DA-B2020-10-21
00818630010586Foxtrot Litter DA, with Tan CarrierAF-LITC-DA-T2020-10-21
00818630014027Foxtrot Litter DA, with Orange CarrierAF-LITC-DA-RO2020-10-21
00818630014508Foxtrot Litter with Orange CarrierAF-LITC-RO2020-10-21
00818630014515Foxtrot Litter with Red CarrierAF-LITC-R2020-10-21
00818630014522Foxtrot Litter DA, with Red CarrierAF-LITC-DA-R2020-10-21
00818630014539Foxtrot Litter DA, with Green CarrierAF-LITC-DA-OD2020-10-21
00818630014546Foxtrot Litter, No CarrierAF-LIT2020-10-21
00818630014553Foxtrot Litter DA, no CarrierAF-LIT-DA2020-10-21
00818630014584Foxtrot Litter with Green CarrierAF-LITC-OD2020-10-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08