FDA.reportPublic FDA data

NAR

Primary DI
00842209127375
Brand
NAR
Company
NORTH AMERICAN RESCUE, LLC
Model
85-4252
Published
2023-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PYIThoracic Catheter Insertion Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PYIThoracic Catheter Insertion TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842209127375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842209127375008422091273758422091273750842209127375

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
832426782
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00842209138081NAR84-019184-01912026-03-24
00842209138098NAR84-019484-01942026-03-24
00842209138104NAR84-019584-01952026-03-24
00842209138111NAR80-196280-19622026-03-24
00842209138128NAR85-506985-50692026-03-24
00842209138135NAR85-508785-50872026-03-24
00842209138142NAR80-189980-18992026-03-24
00842209138159NAR80-190980-19092026-03-24
00842209138166NAR85-507585-50752026-03-24
00842209138173NAR85-508585-50852026-03-24
00842209138180NAR85-509285-50922026-03-24
00842209138197NAR85-509485-50942026-03-24
00842209138203NAR85-509585-50952026-03-24
00842209138210NAR80-197280-19722026-03-24
00842209138227NAR80-197380-19732026-03-24
00842209138234NAR77-013877-01382026-03-24
00842209138241NAR77-013977-01392026-03-24
00842209138258NAR77-014077-01402026-03-24
00842209138265NAR77-014177-01412026-03-24
00842209138272NAR77-014277-01422026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956421156CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
50198956293807CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
50198956380897CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
50198956392562CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
50198956290318CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
50198956350746CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
00842209137459NARNORTH AMERICAN RESCUE, LLCPYI2026-02-10
50198956353112CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956355567CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956328394CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-30
00842209137121NARNORTH AMERICAN RESCUE, LLCPYI2026-01-20
50198956272178CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-15
50198956303612CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-15
50198956258431CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-07
50198956312485CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-07
50198956294316CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-26
50198956296921CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-22
50198956281965CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-19
M689HHCTUINK01040Chest Tube Insertion KitSafeguard US Operating, LLCPYI2025-12-19
M689HHCTUINK0105040Chest Tube Insertion Kit Cast of 5Safeguard US Operating, LLCPYI2025-12-19
50198956287868CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-17
50198956278279CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-12
50198956289817CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-11
50198956264685CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-10
50198956269901CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-09
50198956285901CARDINAL HEALTHCardinal Health 200, LLCPYI2025-12-09
00850063404464easycareSynchronis Medical, LLCPYI2025-12-08
50198956209570CARDINAL HEALTHCardinal Health 200, LLCPYI2025-11-17
50198956266672CARDINAL HEALTHCardinal Health 200, LLCPYI2025-11-17
50198956231632CARDINAL HEALTHCardinal Health 200, LLCPYI2025-11-13