FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106700967
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
AMN422677D
Catalog number
AMN422677D
Device description
KIT, WELCOME ADMISSION B
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PWMAdmission kit (patient utensil)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PWMAdmission Kit (Patient Utensil)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106700967PackageGS120In Commercial Distribution
10197106700969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710670096750197106700967
1019710670096910197106700969

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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.

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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956407275CARDINAL HEALTHCardinal Health 200, LLCPWM2026-02-20
50198956407273CARDINAL HEALTHCardinal Health 200, LLCPWM2026-02-20
10198956392267CARDINAL HEALTHCardinal Health 200, LLCPWM2026-02-12
10198956371972CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-30
50198956371970CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-30
10198956344273CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-15
50198956344271CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-15
10198956331044CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
10198956333116CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
50198956331042CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
50198956333114CARDINAL HEALTHCardinal Health 200, LLCPWM2026-01-05
10198956247574CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
10198956289673CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
50198956247572CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
50198956289671CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-25
10198956286900CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-24
50198956286908CARDINAL HEALTHCardinal Health 200, LLCPWM2025-11-24
10198956119680CARDINAL HEALTHCardinal Health 200, LLCPWM2025-06-13
50198956119688CARDINAL HEALTHCardinal Health 200, LLCPWM2025-06-13
10198956106192CARDINAL HEALTHCardinal Health 200, LLCPWM2025-05-29
50198956106190CARDINAL HEALTHCardinal Health 200, LLCPWM2025-05-29
10198956063884CARDINAL HEALTHCardinal Health 200, LLCPWM2025-04-22
50198956063882CARDINAL HEALTHCardinal Health 200, LLCPWM2025-04-22
10197106822616CARDINAL HEALTHCardinal Health 200, LLCPWM2024-10-28
50197106822614CARDINAL HEALTHCardinal Health 200, LLCPWM2024-10-28
10197106700969CARDINAL HEALTHCardinal Health 200, LLCPWM2024-08-01
10197106630044CARDINAL HEALTHCardinal Health 200, LLCPWM2024-07-08
50197106630042CARDINAL HEALTHCardinal Health 200, LLCPWM2024-07-08
10195594729608CARDINAL HEALTHCardinal Health 200, LLCPWM2022-06-16
50195594729606CARDINAL HEALTHCardinal Health 200, LLCPWM2022-06-16