FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956599406
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN35CC661
Catalog number
SAN35CC661
Device description
CARDIAC CATH PACK NEW GOWN
Published
2026-10-15
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
OEQAngiography/angioplasty kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEQAngiography/Angioplasty KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956599404PackageGS13In Commercial Distribution
10198956599406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895659940450198956599404
1019895659940610198956599406

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 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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956562523CARDINAL HEALTH34-9491A34-9491A2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956571495CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956606869CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
10198956607446CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-15
00884450501832Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-14
00884450385760Merit Medical®Merit Medical Systems, Inc.OEQ2026-10-13
10198956592698CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-13
10198956551282CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956587243CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956595491CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956599369CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956600126CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601611CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956601727CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956602564CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10198956606326CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-12
10809160540510HALYARDAVID MEDICAL, INC.OEQ2026-10-12
10198956391215CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956420526CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956504578CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956517332CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956542228CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956551251CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956556157CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956581715CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956589049CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956590557CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956592711CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956593947CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06
10198956594685CARDINAL HEALTHCardinal Health 200, LLCOEQ2026-10-06