FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594388577
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-2175A
Catalog number
34-2175A
Device description
SINGLE SHOT EPIDURAL TRAY
Published
2021-11-24
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
50195594388575PackageGS128In Commercial Distribution
10195594388577PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559438857550195594388575
1019559438857710195594388577

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia single-administration set, medicatedA collection of devices intended for the single-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent with an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.

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
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
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
10195594090586CARDINAL HEALTHCardinal Health 200, LLCOFV2021-06-16
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