FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10887488976532
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN19CCK12
Catalog number
SAN19CCK12
Device description
STERILE CARDIAC CATH PACK
Published
2018-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OESCardiac catheterization kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OESCardiac Catheterization KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488976530PackageGS14In Commercial Distribution
10887488976532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748897653050887488976530
1088748897653210887488976532

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy suction kitA collection of sterile devices and supplies intended to suction secretions from the trachea and bronchi through a tracheostomy tube. It typically includes a tracheal suctioning catheter with an appropriate tip (e.g., a whistle tip for adults, a smaller one for children) and a thumb operated valve, a pair of gloves, and a container for the aspirates. It is typically intended to be used with a suction machine. Some types include an inner cannula replacement for the tracheostomy tube. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253015553T.E.D.399539952026-06-19
20192253016748Kendall22853228532021-05-19
20192253016755Kendall2285522855-2021-02-23
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253020240Kerlix332433242020-09-22
50192253020197Kerlix189218922020-08-12
50192253020357Kerlix673567352020-08-12
50192253020364Kerlix788278822020-08-12
50192253050422Devon31142931311429312023-07-10
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160537565HalyardAVID MEDICAL, INC.OES2026-09-19
10809160537763HalyardAVID MEDICAL, INC.OES2026-09-19
10809160536711HalyardAVID MEDICAL, INC.OES2026-09-18
10809160537121HalyardAVID MEDICAL, INC.OES2026-09-18
10809160537367HalyardAVID MEDICAL, INC.OES2026-09-18
B098AMS194470Aligned Medical SolutionsAligned Medical SolutionsOES2026-09-18
10198956558687CARDINAL HEALTHCardinal Health 200, LLCOES2026-09-04
10809160532928HalyardAVID MEDICAL, INC.OES2026-09-04
10809160531884HalyardAVID MEDICAL, INC.OES2026-08-27
10809160531891HalyardAVID MEDICAL, INC.OES2026-08-27
10198956557901CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956557918CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10198956561762CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-26
10809160531679HalyardAVID MEDICAL, INC.OES2026-08-26
10809160531273HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531280HalyardAVID MEDICAL, INC.OES2026-08-21
10809160531396HalyardAVID MEDICAL, INC.OES2026-08-21
10809160530801HalyardAVID MEDICAL, INC.OES2026-08-19
10198956546301CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
10198956554481CARDINAL HEALTHCardinal Health 200, LLCOES2026-08-17
B098AMS188600Aligned Medical SolutionsAligned Medical SolutionsOES2026-08-03
10198956543287CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956543614CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10198956544550CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-31
10809160528259HalyardAVID MEDICAL, INC.OES2026-07-31
10198956517776CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956534926CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10198956535404CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-27
10809160527672HalyardAVID MEDICAL, INC.OES2026-07-21
10198956528062CARDINAL HEALTHCardinal Health 200, LLCOES2026-07-20