FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594090586
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-8781A
Catalog number
34-8781A
Device description
SPINAL BLOCK TRAY
Published
2021-06-16
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
OFVRegional anesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFVRegional Anesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594090584PackageGS120In Commercial Distribution
10195594090586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559409058450195594090584
1019559409058610195594090586

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.

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
10192253004649Monoject8602RC8602RC2026-07-09
10192253004656Monoject8605RC8605RC2026-07-09
10192253004663Monoject8607RC8607RC2026-07-09
10192253004700Monoject8617RC8617RC2026-07-09
10192253051575Precision2650SA2650SA2026-07-09
10197106896327CARDINAL HEALTHSNENU0868BSNENU0868B2026-07-09
10198956074668CARDINAL HEALTHSBA37OTMOFSBA37OTMOF2026-07-09
10198956119260CARDINAL HEALTHSBA69MPSUBSBA69MPSUB2026-07-09
10198956119437CARDINAL HEALTHPVVMVPBLGPVVMVPBLG2026-07-09
10198956255586CARDINAL HEALTHSOP53SAPTHSOP53SAPTH2026-07-09
10198956268272CARDINAL HEALTHSMA54CSWMMSMA54CSWMM2026-07-09
10198956286719CARDINAL HEALTHSOT11BR10MSOT11BR10M2026-07-09
10198956307308CARDINAL HEALTHSAN43ADSWOSAN43ADSWO2026-07-09
10198956313576CARDINAL HEALTHSMA69BTDNBSMA69BTDNB2026-07-09
10198956333888CARDINAL HEALTHPBCGLSARGPBCGLSARG2026-07-09
10198956334373CARDINAL HEALTHSNECGBPNODSNECGBPNOD2026-07-09
10198956339132CARDINAL HEALTHSEYHDCAGWHSEYHDCAGWH2026-07-09
10198956345942CARDINAL HEALTHSANOCIRHTBSANOCIRHTB2026-07-09
10198956349834CARDINAL HEALTHSAN73PLCHMSAN73PLCHM2026-07-09
10198956360358CARDINAL HEALTHSCV73VPBHDSCV73VPBHD2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197106780459CARDINAL HEALTHCardinal Health 200, LLCOFV2024-11-07
50197106780457CARDINAL HEALTHCardinal Health 200, LLCOFV2024-11-07
10197106514047CARDINAL HEALTHCardinal Health 200, LLCOFV2024-02-01
50197106514045CARDINAL HEALTHCardinal Health 200, LLCOFV2024-02-01
00851111007002First Medical Source (FMS)First Medical Source, LLCOFV2022-12-16
00851111007101First Medical Source (FMS)First Medical Source, LLCOFV2022-12-16
10195594388577CARDINAL HEALTHCardinal Health 200, LLCOFV2021-11-24
50195594388575CARDINAL HEALTHCardinal Health 200, LLCOFV2021-11-24
10195594280413CARDINAL HEALTHCardinal Health 200, LLCOFV2021-10-07
50195594280411CARDINAL HEALTHCardinal Health 200, LLCOFV2021-10-07
10195594162009CARDINAL HEALTHCardinal Health 200, LLCOFV2021-06-24
50195594162007CARDINAL HEALTHCardinal Health 200, LLCOFV2021-06-24
50195594090584CARDINAL HEALTHCardinal Health 200, LLCOFV2021-06-16
10195594941000CARDINAL HEALTHCardinal Health 200, LLCOFV2021-03-08
50195594941008CARDINAL HEALTHCardinal Health 200, LLCOFV2021-03-08
10195594949761CARDINAL HEALTHCardinal Health 200, LLCOFV2021-02-19
50195594949769CARDINAL HEALTHCardinal Health 200, LLCOFV2021-02-19
10888439930184CARDINAL HEALTHCardinal Health 200, LLCOFV2020-11-25
50888439930182CARDINAL HEALTHCardinal Health 200, LLCOFV2020-11-25
10888439390551CARDINAL HEALTHCardinal Health 200, LLCOFV2019-02-25
50888439390559CARDINAL HEALTHCardinal Health 200, LLCOFV2019-02-25
10887488423074CARDINAL HEALTHCardinal Health 200, LLCOFV2016-08-04
50887488423072CARDINAL HEALTHCardinal Health 200, LLCOFV2016-08-04