FDA.report

CARDINAL HEALTH

Primary DI
50197106524280
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-B0114A
Catalog number
17-B0114A
Device description
EMERGENCY SURGICAL AIRWAY TRAY
Published
2024-01-23
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
OGWTracheostomy kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGWTracheostomy KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106524280PackageGS130In Commercial Distribution
10197106524282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710652428050197106524280
1019710652428210197106524282

GMDN Terms

TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

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
50198956395808CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
50198956396263CARDINAL HEALTHCardinal Health 200, LLCOGW2026-03-02
50198956280364CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-22
50198956291490CARDINAL HEALTHCardinal Health 200, LLCOGW2026-01-05
50198956277128CARDINAL HEALTHCardinal Health 200, LLCOGW2025-12-17
50198956251647CARDINAL HEALTHCardinal Health 200, LLCOGW2025-11-17
50197106893157CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-22
50198956152920CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-07
50198956164091CARDINAL HEALTHCardinal Health 200, LLCOGW2025-08-06
50197106898152CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-16
50198956075960CARDINAL HEALTHCardinal Health 200, LLCOGW2025-06-10
10661392008042LSL HEALTHCARELSL Industries, LLCOGW2025-05-16
50198956082203CARDINAL HEALTHCardinal Health 200, LLCOGW2025-05-15
50198956068993CARDINAL HEALTHCardinal Health 200, LLCOGW2025-05-07
10661392006406LSL HEALTHCARELSL Industries, LLCOGW2025-04-22
50198956027440CARDINAL HEALTHCardinal Health 200, LLCOGW2025-04-08
50198956013924CARDINAL HEALTHCardinal Health 200, LLCOGW2025-03-31
50198956008951CARDINAL HEALTHCardinal Health 200, LLCOGW2025-03-25
50197106986293CARDINAL HEALTHCardinal Health 200, LLCOGW2025-03-11
50197106789467CARDINAL HEALTHCardinal Health 200, LLCOGW2025-02-10
50197106922567CARDINAL HEALTHCardinal Health 200, LLCOGW2025-01-28
50197106888962CARDINAL HEALTHCardinal Health 200, LLCOGW2024-12-31
50197106729043CARDINAL HEALTHCardinal Health 200, LLCOGW2024-10-09
50197106786077CARDINAL HEALTHCardinal Health 200, LLCOGW2024-09-26
50197106760237CARDINAL HEALTHCardinal Health 200, LLCOGW2024-09-09
50197106593927CARDINAL HEALTHCardinal Health 200, LLCOGW2024-08-23
50197106652228CARDINAL HEALTHCardinal Health 200, LLCOGW2024-07-10
50197106715992CARDINAL HEALTHCardinal Health 200, LLCOGW2024-07-08
50197106667871CARDINAL HEALTHCardinal Health 200, LLCOGW2024-05-23
50197106631582CARDINAL HEALTHCardinal Health 200, LLCOGW2024-05-22