FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106110957
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
OTC
false
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.

Sterilization Methods#

Method table
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

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
10197106110959CARDINAL 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