FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956394773
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-5117B
Catalog number
34-5117B
Device description
PAIN TRAY
Published
2026-08-17
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
OFQAnesthesia kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFQAnesthesia KitAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50198956394771PackageGS110In Commercial Distribution
10198956394773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895639477150198956394771
1019895639477310198956394773

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 Temperature00

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
10192253048049Kendall924492442026-06-15
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253047943Kendall92319231-2026-05-12
10192253047950Kendall923292322026-05-12
10192253048087Kendall93519351-2024-03-04
10192253048094Kendall93549354-2024-03-04
10192253048100Kendall93559355-2024-03-04
10192253048117Kendall93569356-2024-03-04
10192253047967Kendall92339233-2026-05-26
10198956361003CARDINAL HEALTHSOTOCURGRBSOTOCURGRB2026-08-18
10198956366107CARDINAL HEALTH34-2285H34-2285H2026-08-18
10198956381100CARDINAL HEALTH34-7731C34-7731C2026-08-18
10198956463738CARDINAL HEALTHPE23EANLDPE23EANLD2026-08-18
10198956469990CARDINAL HEALTHSNE54LCDECSNE54LCDEC2026-08-18
10198956502512CARDINAL HEALTHSCVDHAPMCLSCVDHAPMCL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956547360CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956551442CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956533066CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17
10198956461734CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956511798CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956524651CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956530706CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531024CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956531031CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-27
10198956435728CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956524613CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-20
10198956518650CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-07-16
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
10195594419592CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-05-09
H65857030615Henry ScheinHENRY SCHEIN, INC.OFQ2022-04-29
10195594375423CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-15
10195594450717CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-10
10195594501136CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-07
10195594492106CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-03-01
10195594476199CARDINAL HEALTHCardinal Health 200, LLCOFQ2022-02-26