FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439845394
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMAHFCBSH1
Catalog number
SMAHFCBSH1
Device description
CPT, C SECTION PACK WITH BASIN
Published
2020-06-15
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
OHMCesarean section tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHMCesarean Section TrayObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439845394PackageGS12In Commercial Distribution
10888439845396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843984539450888439845394
1088843984539610888439845396

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, medicatedA collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. 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
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
10198956312920CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956482203CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956495234CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956497832CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956498129CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956499249CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-08
10198956231061CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956453227CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956466029CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956487239CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956489370CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956491984CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956493964CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956496323CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-05
10198956467378CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956488120CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956489523CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956490444CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956490918CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-03
10198956460614CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956462250CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956480056CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956487512CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956487574CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956489431CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10198956493148CARDINAL HEALTHCardinal Health 200, LLCOHM2026-06-01
10080196943470Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2025-02-16
10080196887545Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-07-29
10193489441772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-13
10193489212624Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08