FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956284524
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA30XPPRD
Catalog number
SMA30XPPRD
Device description
MPHSA OB PACK
Published
2026-09-30
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
OKVObstetrical kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKVObstetrical KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956284522PackageGS12In Commercial Distribution
10198956284524PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895628452250198956284522
1019895628452410198956284524

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 Temperature00

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
10198956428201CARDINAL HEALTH26-2755C26-2755C2026-10-01
10198956512474CARDINAL HEALTH28A5420I28A5420I2026-10-01
10198956524316CARDINAL HEALTH34A5387R34A5387R2026-10-01
10198956537385CARDINAL HEALTH28-6325B28-6325B2026-10-01
10198956563087CARDINAL HEALTH34-2454E34-2454E2026-10-01
10198956587298CARDINAL HEALTH40-6487C40-6487C2026-10-01
10885380214714Curity8441368441362026-09-30
10885380214738Curity8441568441562026-09-30
10885380214707Curity8441268441262026-09-28
10885380214721Curity8441468441462026-09-28
10885380214745Curity8441668441662026-09-28
10885380214752Curity8441768441762026-09-28
10885380214769Curity8442168442162026-09-28
10885380214776Curity8442268442262026-09-28
10885380214783Curity8442368442362026-09-28
10885380214790Curity8442468442462026-09-28
10885380214806Curity8442568442562026-09-28
20192253017561Medi-Trace Cadence22660P22660P2024-02-28
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
50885380050365CARDINAL HEALTHCA901CHCA901CH2021-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160538944HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538982HalyardAVID MEDICAL, INC.OKV2026-09-24
10809160538586HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538623HalyardAVID MEDICAL, INC.OKV2026-09-22
10809160538180HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538302HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538463HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160538500HalyardAVID MEDICAL, INC.OKV2026-09-21
10809160537619HalyardAVID MEDICAL, INC.OKV2026-09-19
10809160537800HALYARDAVID MEDICAL, INC.OKV2026-09-19
10809160536568HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160536650HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537008HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537022HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160537053HalyardAVID MEDICAL, INC.OKV2026-09-18
10809160532690HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532805HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532843HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532850HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160532881HalyardAVID MEDICAL, INC.OKV2026-09-04
10809160531853HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531938HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531969HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532027HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532065HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160532096HalyardAVID MEDICAL, INC.OKV2026-08-27
10809160531747HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531761HalyardAVID MEDICAL, INC.OKV2026-08-26
10809160531327HalyardAVID MEDICAL, INC.OKV2026-08-21
10809160531402HalyardAVID MEDICAL, INC.OKV2026-08-21