FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50887488290711
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
17-0113A
Catalog number
17-0113A
Device description
STERILE COLLECTION VIAL KIT
Published
2017-02-04
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
KDTCONTAINER, SPECIMEN MAILER AND STORAGE, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDTContainer, Specimen Mailer And Storage, SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50887488290711PackageGS150In Commercial Distribution
10887488290713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088748829071150887488290711
1088748829071310887488290713

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

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
false
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
G669CNPTLS1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, SterileCorramedical Inc.KDT2026-04-07
10809160466940Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDT2025-05-15
10198459217074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDT2024-12-22
30193489107337MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
30193489107344MedlineMEDLINE INDUSTRIES, INC.KDT2024-03-05
18053326004534BC+™ COPAN ITALIA SPAKDT2022-12-07
38053326010966UriFreeCOPAN ITALIA SPAKDT2022-12-07
00613647005958FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KDT2022-12-07
14039943000016CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000023CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000030CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000047CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000054CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000061CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000085CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000092CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000108CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000115CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000122CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000139CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000146CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000153CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000160CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000177CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000184CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000191CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000207CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000214CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000221CRYO.SGreiner Bio - One GmbHKDT2022-12-06
14039943000238CRYO.SGreiner Bio - One GmbHKDT2022-12-06