FDA.report

CARDINAL HEALTH

Primary DI
50195594734280
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA15GIFC6
Catalog number
SBA15GIFC6
Device description
GI CHEST TUBE INSERTION PACK
Published
2022-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PYIThoracic catheter insertion tray

Product Code Classifications

CodeDeviceSpecialtyClass
PYIThoracic Catheter Insertion TrayGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50195594734280PackageGS17In Commercial Distribution
10195594734282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559473428050195594734280
1019559473428210195594734282

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

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