FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594702807
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
ORO8108615
Catalog number
ORO8108615
Device description
KIT,OB DLVRY, BERGAN MERCY,6 C
Published
2022-05-31
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
MLADNA PROBE, YEAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLADna Probe, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594702807PackageGS16In Commercial Distribution
10195594702809PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559470280750195594702807
1019559470280910195594702809

GMDN Terms#

Term, Definition table
TermDefinition
Birthing/delivery kitA collection of sterile devices designed for the procedures associated with the birthing and delivery of a newborn. It contains the necessary instruments, dressings, and pharmaceuticals necessary for this procedure. 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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956102217CARDINAL HEALTHCardinal Health 200, LLCMLA2025-06-05
50198956102215CARDINAL HEALTHCardinal Health 200, LLCMLA2025-06-05
10197106086612CARDINAL HEALTHCardinal Health 200, LLCMLA2022-12-15
10195594702809CARDINAL HEALTHCardinal Health 200, LLCMLA2022-05-31
10195594572495CARDINAL HEALTHCardinal Health 200, LLCMLA2022-02-21
50195594572493CARDINAL HEALTHCardinal Health 200, LLCMLA2022-02-21
00382904462529BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMLA2018-05-25
00382904462574BD Affirm™ VPIII Microbial Identification TestBECTON, DICKINSON AND COMPANYMLA2018-05-25