FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594010070
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
PBMVLGN11
Catalog number
PBMVLGN11
Device description
KIT, PRENTICE LAP DAVINCI
Published
2021-04-12
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
OHDGynecological laparoscopic kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHDGynecological Laparoscopic KitObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594010070PackageGS12In Commercial Distribution
10195594010072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559401007050195594010070
1019559401007210195594010072

GMDN Terms#

Term, Definition table
TermDefinition
Amniocentesis kit, non-medicatedA collection of sterile devices designed to aspirate and contain a sample of amniotic fluid from the amniotic sac, via a transabdominal approach, for analysis. Components typically include a needle with stylet and syringe, specimen containers/medium, drapes, and dressings. The device is typically used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities (e.g., Down syndrome, spina bifida), or anytime after 24-weeks gestation to assess foetal maturity. 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
10197106992753CARDINAL HEALTHSCV40VP52CSCV40VP52C2026-09-25
10198956169357CARDINAL HEALTHSCV69EVWKASCV69EVWKA2026-09-25
10198956172715CARDINAL HEALTHSBA21PPSCCSBA21PPSCC2026-09-25
10198956321335CARDINAL HEALTHPEHDTRVCKPEHDTRVCK2026-09-25
10198956339729CARDINAL HEALTHSBA22ATMRASBA22ATMRA2026-09-25
10198956374232CARDINAL HEALTHSOP41KASRBSOP41KASRB2026-09-25
10198956383043CARDINAL HEALTHORC3R7765BORC3R7765B2026-09-25
10198956388239CARDINAL HEALTHSOT53CYPOFSOT53CYPOF2026-09-25
10198956393288CARDINAL HEALTHSBA73GPMVBSBA73GPMVB2026-09-25
10198956400801CARDINAL HEALTHSOP3MHPCVCSOP3MHPCVC2026-09-25
10198956402522CARDINAL HEALTHSMA13GLEXDSMA13GLEXD2026-09-25
10198956424654CARDINAL HEALTHPO54TKCMDPO54TKCMD2026-09-25
10198956439849CARDINAL HEALTHSAN69PCKOGSAN69PCKOG2026-09-25
10198956444263CARDINAL HEALTHPV36HPCHEPV36HPCHE2026-09-25
10198956450684CARDINAL HEALTHSMA58CSLOPSMA58CSLOP2026-09-25
10198956461086CARDINAL HEALTHSBACGBPGSHSBACGBPGSH2026-09-25
10198956462205CARDINAL HEALTHPV08TCGHHPV08TCGHH2026-09-25
10198956466159CARDINAL HEALTH03-2656S03-2656S2026-09-25
10198956466838CARDINAL HEALTHSNE35LSFSGSNE35LSFSG2026-09-25
10198956484382CARDINAL HEALTHANE306276AANE306276A2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186920Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-26
10198956402522CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956485778CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956545953CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956547414CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956557109CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956567733CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956570764CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956587991CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-25
10198956333758CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956346222CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956507807CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956539372CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956543423CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567689CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956567801CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956570115CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956577848CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956579613CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956580558CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581043CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956581975CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956583436CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956589216CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-22
10198956439610CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956521452CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956534278CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956571488CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
10198956576360CARDINAL HEALTHCardinal Health 200, LLCOHD2026-09-21
B098AMS197460Aligned Medical SolutionsAligned Medical SolutionsOHD2026-09-18