FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106538782
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
41-6901D
Catalog number
41-6901D
Device description
HMH USG IV KIT
Published
2024-04-16
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
OWLPeripheral catheter insertion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106538782PackageGS127In Commercial Distribution
10197106538784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710653878250197106538782
1019710653878410197106538784

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
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
10198956446625CARDINAL HEALTHCardinal Health 200, LLCOWL2026-05-08
10198956393493CARDINAL HEALTHCardinal Health 200, LLCOWL2026-03-31
10198956291669CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
10198956188129CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
10198956266667CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
10198956263550CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
10198956257115CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
10198956255449CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-03
10198956229334CARDINAL HEALTHCardinal Health 200, LLCOWL2025-10-15
10198956184459CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
10198956165434CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
10197106694800CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10198956067981CARDINAL HEALTHCardinal Health 200, LLCOWL2025-05-05
10198956048850CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-17
10198956033917CARDINAL HEALTHCardinal Health 200, LLCOWL2025-04-09
10198956024274CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-31
10198956012912CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-25
10197106982013CARDINAL HEALTHCardinal Health 200, LLCOWL2025-03-05
10197106892749CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-21
10197106953310CARDINAL HEALTHCardinal Health 200, LLCOWL2025-02-18
10197106773017CARDINAL HEALTHCardinal Health 200, LLCOWL2024-11-13
10197106650776CARDINAL HEALTHCardinal Health 200, LLCOWL2024-06-10
10197106538784CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-16
10197106611067CARDINAL HEALTHCardinal Health 200, LLCOWL2024-04-11
10197106544327CARDINAL HEALTHCardinal Health 200, LLCOWL2024-01-22
10197106499498CARDINAL HEALTHCardinal Health 200, LLCOWL2023-12-06
10197106488959CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-28
10197106427477CARDINAL HEALTHCardinal Health 200, LLCOWL2023-11-27
10197106472781CARDINAL HEALTHCardinal Health 200, LLCOWL2023-10-31
10197106442197CARDINAL HEALTHCardinal Health 200, LLCOWL2023-09-19