FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594108258
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-0075A
Catalog number
34-0075A
Device description
SPINAL KIT
Published
2021-09-24
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
OFUSpinal anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594108258PackageGS120In Commercial Distribution
10195594108250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559410825850195594108258
1019559410825010195594108250

GMDN Terms#

Term, Definition table
TermDefinition
Intrathecal anaesthesia set, medicatedA collection of devices intended for the single-administration of an analgesic or anaesthetic agent to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes the pharmaceutical anaesthetic agent, spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. 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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955672370Design Options®B. BRAUN MEDICAL INC.OFU2026-05-24
50198956359329CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956406801CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956421170CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-23
50198956393347CARDINAL HEALTHCardinal Health 200, LLCOFU2026-03-19
50198956364620CARDINAL HEALTHCardinal Health 200, LLCOFU2026-02-09
50198956238730CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
50198956343601CARDINAL HEALTHCardinal Health 200, LLCOFU2026-01-22
50198956270747CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-29
50198956266511CARDINAL HEALTHCardinal Health 200, LLCOFU2025-12-26
04046955672028Design Options®B. BRAUN MEDICAL INC.OFU2025-12-22
04046961012641Design Options®B. BRAUN MEDICAL INC.OFU2025-08-31
50198956169591CARDINAL HEALTHCardinal Health 200, LLCOFU2025-08-13
50198956133691CARDINAL HEALTHCardinal Health 200, LLCOFU2025-07-21
50198956099638CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-20
50198956080650CARDINAL HEALTHCardinal Health 200, LLCOFU2025-06-10
04046955672004Design Options®B. BRAUN MEDICAL INC.OFU2025-04-27
50197106924134CARDINAL HEALTHCardinal Health 200, LLCOFU2025-04-03
50198956009651CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-31
50198956007244CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-25
50197106980246CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-14
50197106955466CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-11
50197106839353CARDINAL HEALTHCardinal Health 200, LLCOFU2025-03-10
50197106938513CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-28
50197106951987CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-21
50197106882953CARDINAL HEALTHCardinal Health 200, LLCOFU2025-02-03
50197106887279CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-30
50197106907328CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-30
50197106878611CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-21
50197106879694CARDINAL HEALTHCardinal Health 200, LLCOFU2025-01-06