FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956392564
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER13TRE21
Catalog number
SER13TRE21
Device description
CHEST TUBE INSERTION PACK
Published
2026-03-02
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
50198956392562PackageGS120In Commercial Distribution
10198956392564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895639256250198956392562
1019895639256410198956392564

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10192253004243Monoject31143699311436992026-08-03
10192253004250Monoject31143798311437982026-08-03
10192253004304Monoject31300878313008782026-08-03
20192253050353Vistec659165912023-05-24
10192253004458Monoject85121851212026-07-31
10192253004465Monoject8513018513012026-07-31
10192253004472Monoject85131851312026-07-31
10192253004915Monoject890689062026-07-31
10192253005066Monoject89671896712026-07-31
10192253005295Monoject8990Y8990Y2026-07-31
10192253005516Monoject8535Y8535Y2026-07-31
10192253005622Monoject8970Y8970Y2026-07-31
10197106933145CARDINAL HEALTHPV42CJTMZPV42CJTMZ2026-07-31
10197106950012CARDINAL HEALTHSAN56IPIDFSAN56IPIDF2026-07-31
10198956027596CARDINAL HEALTHSCV73CAHFHSCV73CAHFH2026-07-31
10198956327603CARDINAL HEALTH26-8545D26-8545D2026-07-31
10198956342217CARDINAL HEALTHPB15LHFCLPB15LHFCL2026-07-31
10198956352315CARDINAL HEALTHPW45KFMSAPW45KFMSA2026-07-31
10198956353961CARDINAL HEALTHSNEHBNEECDSNEHBNEECD2026-07-31
10198956364998CARDINAL HEALTHSBADHHMCFDSBADHHMCFD2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956530874CARDINAL HEALTHCardinal Health 200, LLCPYI2026-07-31
10198956477308CARDINAL HEALTHCardinal Health 200, LLCPYI2026-07-27
10198956532199CARDINAL HEALTHCardinal Health 200, LLCPYI2026-07-27
10198956534247CARDINAL HEALTHCardinal Health 200, LLCPYI2026-07-27
10198956464995CARDINAL HEALTHCardinal Health 200, LLCPYI2026-07-20
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
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