FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50888439839744
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SANDHCLRAA
Catalog number
SANDHCLRAA
Device description
ANGIO DRAPE PACK NEURO
Published
2020-07-27
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
OJGNeurological tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJGNeurological TrayNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50888439839744PackageGS12In Commercial Distribution
10888439839746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843983974450888439839744
1088843983974610888439839746

GMDN Terms#

Term, Definition table
TermDefinition
Angiography kitA collection of sterile devices and equipment used to prepare a patient for the radiographic visualization of the arteries of a particular organ system or body part through the vascular injection of contrast media. It typically includes a combination of fluid/contrast media administration devices (e.g., tubing, manifold, stopcocks, and syringes) and/or dedicated angiography supportive devices (e.g., angiography drapes, covers, dressings); the angiography catheter is not included. 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
10809160522561HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522578HalyardAVID MEDICAL, INC.OJG2026-06-04
10809160522615HalyardAVID MEDICAL, INC.OJG2026-06-04
10198956477452CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956483910CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956492257CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956496842CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956496859CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956498235CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10198956499478CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-03
10809160522417HalyardAVID MEDICAL, INC.OJG2026-06-02
10198956352711CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956362611CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956384422CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956400238CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956450530CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956454897CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956473218CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956475571CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956480629CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487178CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956487536CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489288CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956489325CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956491168CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10198956493056CARDINAL HEALTHCardinal Health 200, LLCOJG2026-06-01
10809160521908HalyardAVID MEDICAL, INC.OJG2026-05-27
10193489375657NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10193489376845NAMICMEDLINE INDUSTRIES, INC.OJG2026-05-21
10080196471096NAMICMEDLINE INDUSTRIES, INC.OJG2026-04-24