FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106477182
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SOTMICPSIE
Catalog number
SOTMICPSIE
Device description
CYSTO PACK
Published
2023-11-27
Public version status
New
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
NWAProsthesis, tracheal, preformed/molded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWAProsthesis, Tracheal, Preformed/MoldedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106477180PackageGS19In Commercial Distribution
10197106477182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710647718050197106477180
1019710647718210197106477182

GMDN Terms#

Term, Definition table
TermDefinition
Sexual lubricantA substance (e.g., a gel or jelly) intended to be applied to the penis, vagina and/or anus for lubrication during sexual intercourse or to be used with a sexual vibrator. This substance contains no pharmaceutical ingredients. After application, this device cannot be reused.

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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14063108100969TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100976TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100983TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108100990TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101003TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101010TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
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14063108101034TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
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14063108101058TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
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14063108101072TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101089TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101096TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101270TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101287TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101294TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101300TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101324TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101331TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101348TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101355TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101362TRACHEOBRONXANE™ DUMON®NOVATECHNWA2024-11-22
14063108101942TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22
14063108101959TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22
14063108101966TRACHEOBRONXANE™ DUMON® RADIOPAQUENOVATECHNWA2024-11-22