FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956433625
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA15GIFC8
Catalog number
SBA15GIFC8
Device description
GI CHEST TUBE INSERTION PACK
Published
2026-03-31
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
50198956433623PackageGS17In Commercial Distribution
10198956433625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895643362350198956433623
1019895643362510198956433625

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, 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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00842209137121NARNORTH AMERICAN RESCUE, LLCPYI2026-01-20
10198956272170CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-15
10198956303614CARDINAL HEALTHCardinal Health 200, LLCPYI2026-01-15