FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488517559
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
13-6568B
Catalog number
13-6568B
Device description
STERILE SINGLE SHOT CAUDAL PK
Published
2016-08-03
Public version status
Update
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
OGBCaudal anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OGBCaudal Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488517559PackageGS115In Commercial Distribution
10887488517551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748851755950887488517559
1088748851755110887488517551

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA general-purpose collection of various surgical instruments, dressings, and materials, including a pharmaceutical component, intended to be used to assist a range of surgical procedures across multiple clinical specialities. 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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887488873930CARDINAL HEALTHCardinal Health 200, LLCOGB2017-12-01
50887488873938CARDINAL HEALTHCardinal Health 200, LLCOGB2017-12-01
10887488790725CARDINAL HEALTHCardinal Health 200, LLCOGB2017-09-12
50887488790723CARDINAL HEALTHCardinal Health 200, LLCOGB2017-09-12
10887488517551CARDINAL HEALTHCardinal Health 200, LLCOGB2016-08-03
10887488564395CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-28
50887488564393CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-28
10885425321261CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-18
50885425321269CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-18
10887488441764CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-15
50887488441762CARDINAL HEALTHCardinal Health 200, LLCOGB2016-07-15