FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594752941
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-2477C
Catalog number
34-2477C
Device description
INJECTION TRAY
Published
2022-07-15
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594752949PackageGS118In Commercial Distribution
10195594752941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559475294950195594752949
1019559475294110195594752941

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. 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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956437500CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-09
10198956202320CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956381124CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956520196CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-06
10198956381070CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-23
10198956486232CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-05
10198956454705CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-03
10198956405004CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-06-01
H65857032365Henry ScheinHENRY SCHEIN, INC.OFQ2022-12-12
H65857032105Henry ScheinHENRY SCHEIN, INC.OFQ2022-10-25
H65857032025Henry ScheinHENRY SCHEIN, INC.OFQ2022-09-19
10195594520434CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-09-02
10195594516130CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-07-21
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
H65857030615Henry ScheinHENRY SCHEIN, INC.OFQ2022-04-29
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594516338CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594509859CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-14
10195594450717CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-10
10195594501136CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519902CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594519919CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594492106CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-01
10195594476199CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-26
10195594456221CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-15
10195594487225CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-11
10195594500009CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594520601CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-10
10195594461188CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-08
10195594503772CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-07