FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106110959
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
24A0585B
Catalog number
24A0585B
Device description
CRICO TRAY
Published
2023-02-22
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
OGPCricothyrotomy kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGPCricothyrotomy KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106110957PackageGS115In Commercial Distribution
10197106110959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710611095750197106110957
1019710611095910197106110959

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, single-useA collection of various sterile ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842209138586NARNORTH AMERICAN RESCUE, LLCOGP2026-04-22
10198956284685CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
50198956284683CARDINAL HEALTHCardinal Health 200, LLCOGP2026-01-16
00850063404433ForwardSynchronis Medical, LLCOGP2025-12-31
00850063404440ForwardSynchronis Medical, LLCOGP2025-12-31
M689HHECT01040Emergency Cric KitSafeguard US Operating, LLCOGP2025-12-19
10198956257818CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
50198956257816CARDINAL HEALTHCardinal Health 200, LLCOGP2025-12-11
00850070635066Endotracheal KitNar Medical Depot, LLCOGP2025-12-01
00850062467132Universal Stylette Bougie Assisted Cricothyrotomy (USBCR)Altitude Technologies Inc.OGP2025-08-04
00860009615564Endotracheal KitNar Medical Depot, LLCOGP2025-07-21
10198956054233CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
50198956054231CARDINAL HEALTHCardinal Health 200, LLCOGP2025-05-29
00842209135066NARNORTH AMERICAN RESCUE, LLCOGP2025-05-21
00842209133789NARNORTH AMERICAN RESCUE, LLCOGP2024-12-18
00842209130597NARNORTH AMERICAN RESCUE, LLCOGP2024-03-13
00842209130337NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209130368NARNORTH AMERICAN RESCUE, LLCOGP2024-02-28
00842209129690TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2024-01-17
00842209129249TACTICAL CricKITNORTH AMERICAN RESCUE, LLCOGP2023-11-16
00842209128327NARNORTH AMERICAN RESCUE, LLCOGP2023-08-24
00842209127658NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127665NARNORTH AMERICAN RESCUE, LLCOGP2023-06-29
00842209127481NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209127580NARNORTH AMERICAN RESCUE, LLCOGP2023-06-13
00842209126576NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
00842209126590NARNORTH AMERICAN RESCUE, LLCOGP2023-03-22
50197106110957CARDINAL HEALTHCardinal Health 200, LLCOGP2023-02-22
M689HHSCK01EA020Simplified Cricothyrotomy KitSafeguard US Operating, LLCOGP2022-08-10
M689HHSCK01020H&H Simplified Cric Kit Safeguard US Operating, LLCOGP2022-08-09