FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594695965
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER13TRE13
Catalog number
SER13TRE13
Device description
CHEST TUBE INSERTION PACK
Published
2022-06-08
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
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
50195594695963PackageGS120In Commercial Distribution
10195594695965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559469596350195594695963
1019559469596510195594695965

GMDN Terms#

Term, Definition table
TermDefinition
Cardiothoracic surgical procedure kit, non-medicated, single-useA collection of various sterile cardiothoracic surgical instruments, dressings, and materials intended to be used to assist a range of cardiothoracic surgical procedures; it does not contain pharmaceuticals. The kit is intended only for use during cardiothoracic surgery but is not dedicated to a specific type of cardiothoracic surgical procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M689HHCTUINK01050Chest Tube Insertion KitSafeguard US Operating, LLCPYI2026-05-27
M689HHCTUINK0105050Chest Tube Insertion Kit Cast of 5Safeguard US Operating, LLCPYI2026-05-27
10198956361799CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-19
10198956471160CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-08
10198956453777CARDINAL HEALTHCardinal Health 200, LLCPYI2026-05-04
10198956398733CARDINAL HEALTHCardinal Health 200, LLCPYI2026-04-21
00850056748605EMS Chest Tube Insertion Kit, 24FrINTEGRATED MEDCRAFT LLCPYI2026-04-14
10198956402805CARDINAL HEALTHCardinal Health 200, LLCPYI2026-04-07
00842209138296NARNORTH AMERICAN RESCUE, LLCPYI2026-04-07
10198956433625CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-31
10198956421158CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
50198956421156CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-24
10198956293809CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
50198956293807CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-23
10198956380899CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
50198956380897CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-09
00850056748551Finger Thoracostomy KitINTEGRATED MEDCRAFT LLCPYI2026-03-03
10198956392564CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
50198956392562CARDINAL HEALTHCardinal Health 200, LLCPYI2026-03-02
10198956290310CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
50198956290318CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-23
10198956350748CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
50198956350746CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-13
00842209137459NARNORTH AMERICAN RESCUE, LLCPYI2026-02-10
10198956353114CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
10198956355569CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956353112CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
50198956355567CARDINAL HEALTHCardinal Health 200, LLCPYI2026-02-09
10198956328396CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-30
50198956328394CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-30