FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594480271
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
20-0557D
Catalog number
20-0557D
Device description
NURSERY UMBILICAL TRAY
Published
2021-12-16
Public version status
Update
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
OIANeonatal blood collection kit and screening form (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIANeonatal Blood Collection Kit And Screening Form (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594480279PackageGS124In Commercial Distribution
10195594480271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559448027950195594480279
1019559448027110195594480271

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

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
10192253033502Monoject118030055511803005552022-10-21
10630140029332CONVERTORS29459294592016-06-28
10630140031403CONVERTORS29461294612016-06-28
10885380026577CONVERTORS29435294352016-06-28
10885380034862CONVERTORS74210742102016-06-28
10885380038075CONVERTORS29520295202016-06-28
10885380053740CONVERTORS29456294562016-06-22
10885380058134CONVERTORSD1062D10622016-06-29
10885380058387CONVERTORS945094502016-06-28
10885380062278CONVERTORS944494442016-06-22
10885380062285CONVERTORS755475542016-06-28
10885380062308CONVERTORS955695562016-07-08
10885380063664CONVERTORS29452294522016-06-28
10885380071539CONVERTORS956295622016-07-13
10885380071652CONVERTORS29417294172016-06-28
10885380071690CONVERTORS29458294582016-06-28
10885380108624CONVERTORS29430294302016-06-22
10885380108648CONVERTORS29447294472016-06-22
10885380108655CONVERTORS29448294482016-06-22
10885380108662CONVERTORS29449294492016-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860010959244US Biotek LaboratoriesU.S. Biotek Laboratories LLCOIA2023-09-15
10195594816155CARDINAL HEALTHCardinal Health 200, LLCOIA2022-10-12
50195594816153CARDINAL HEALTHCardinal Health 200, LLCOIA2022-10-12
10195594508685CARDINAL HEALTHCardinal Health 200, LLCOIA2022-05-13
50195594508683CARDINAL HEALTHCardinal Health 200, LLCOIA2022-05-13
50195594480279CARDINAL HEALTHCardinal Health 200, LLCOIA2021-12-16
10195594325312CARDINAL HEALTHCardinal Health 200, LLCOIA2021-09-29
50195594325310CARDINAL HEALTHCardinal Health 200, LLCOIA2021-09-29
10888439229752CARDINAL HEALTHCardinal Health 200, LLCOIA2018-11-13
50888439229750CARDINAL HEALTHCardinal Health 200, LLCOIA2018-11-13