FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106471607
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
MAT4397442
Catalog number
MAT4397442
Device description
KIT,MATERNITY
Published
2023-10-05
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
PAAAutomated breast ultrasound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAAAutomated Breast UltrasoundUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106471607PackageGS18In Commercial Distribution
10197106471609PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710647160750197106471607
1019710647160910197106471609

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.

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
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
00195278756138InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-12
00195278756237InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2025-03-04
10197106527344CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
50197106527342CARDINAL HEALTHCardinal Health 200, LLCPAA2024-02-02
10197106530061CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
50197106530069CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-21
10197106493168CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
50197106493166CARDINAL HEALTHCardinal Health 200, LLCPAA2023-12-14
10197106471609CARDINAL HEALTHCardinal Health 200, LLCPAA2023-10-05
10197106038543CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
50197106038541CARDINAL HEALTHCardinal Health 200, LLCPAA2023-06-05
10197106192573CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
50197106192571CARDINAL HEALTHCardinal Health 200, LLCPAA2023-03-30
00860000221306SoftVueDelphinus Medical Technologies, IncPAA2022-12-07
10195594787271CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
50195594787279CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-12
10195594783907CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
50195594783905CARDINAL HEALTHCardinal Health 200, LLCPAA2022-08-10
00840682141161InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2018-09-04
10885425282814CARDINAL HEALTHCARDINAL HEALTH 200, LLCPAA2016-07-27
50885425282812CARDINAL HEALTHCardinal Health 200, LLCPAA2016-07-27
00840682100090InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2016-01-29
00840682100014InveniaGE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLCPAA2014-09-24
00840682100021InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24
00840682100038InveniaGE Medical Systems, Ultrasound & Primary Care Diagnostics LLCPAA2014-09-24