FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956493148
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA22CBW15
Catalog number
SMA22CBW15
Device description
C BIRTH SET UP PACK
Published
2026-06-01
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
50198956493146PackageGS12In Commercial Distribution
10198956493148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895649314650198956493146
1019895649314810198956493148

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical/gynaecological surgical procedure kit, non-medicated, single-useA collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device.

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
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
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
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
10193489417081Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489418163Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489418989Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489419108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420524Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420739Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489420876Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489423112Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489423181Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489424423Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489425598Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489426267Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489426434Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489428711Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08
10193489429534Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHM2023-06-08