FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106140329
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
03A6744B
Catalog number
03A6744B
Device description
PORT DRESSING CHANGE TRAY
Published
2023-07-06
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

Product Codes#

Code, Name table
CodeName
LRAHearing aid, tactile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRAHearing Aid, TactileUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106140329PackageGS130In Commercial Distribution
10197106140321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710614032950197106140329
1019710614032110197106140321

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

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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956101357CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10198956102637CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956101355CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
50198956102635CARDINAL HEALTHCardinal Health 200, LLCLRA2025-06-05
10197106833261CARDINAL HEALTHCardinal Health 200, LLCLRA2024-12-10
10197106767566CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
50197106767564CARDINAL HEALTHCardinal Health 200, LLCLRA2024-10-15
10197106754641CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
50197106754649CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-27
10197106780855CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
50197106780853CARDINAL HEALTHCardinal Health 200, LLCLRA2024-09-24
10197106738931CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
50197106738939CARDINAL HEALTHCardinal Health 200, LLCLRA2024-08-21
10197106660010CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106677438CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106660018CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
50197106677436CARDINAL HEALTHCardinal Health 200, LLCLRA2024-07-05
10197106602065CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
50197106602063CARDINAL HEALTHCardinal Health 200, LLCLRA2024-04-24
10197106604434CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
50197106604432CARDINAL HEALTHCardinal Health 200, LLCLRA2024-03-20
10197106583982CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
50197106583980CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-15
10197106569122CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106577585CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106569120CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
50197106577583CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-12
10197106564394CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
50197106564392CARDINAL HEALTHCardinal Health 200, LLCLRA2024-02-02
10197106513279CARDINAL HEALTHCardinal Health 200, LLCLRA2024-01-23