FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10198956562523
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-9491A
Catalog number
34-9491A
Device description
PAIN TRAY
Published
2026-10-15
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
50198956562521PackageGS125In Commercial Distribution
10198956562523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895656252150198956562521
1019895656252310198956562523

GMDN Terms#

Term, Definition table
TermDefinition
Intrathecal anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes a 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 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
10198956448025CARDINAL HEALTH11-9002NSC11-9002NSC2026-10-15
10198956531666CARDINAL HEALTH03L2276A03L2276A2026-10-15
10198956538030CARDINAL HEALTHSOP48KASUFSOP48KASUF2026-10-15
10198956542075CARDINAL HEALTH34-8052I34-8052I2026-10-15
10198956543577CARDINAL HEALTHSNE21CRCAHSNE21CRCAH2026-10-15
10198956544017CARDINAL HEALTHSMA54RPUPFSMA54RPUPF2026-10-15
10198956546424CARDINAL HEALTHSOP53SAFOHSOP53SAFOH2026-10-15
10198956549760CARDINAL HEALTHSUT11BAMMCSUT11BAMMC2026-10-15
10198956555211CARDINAL HEALTHSOP43KAIBDSOP43KAIBD2026-10-15
10198956560765CARDINAL HEALTHSAN54SMPTDSAN54SMPTD2026-10-15
10198956561311CARDINAL HEALTHPO54PSJHCPO54PSJHC2026-10-15
10198956563056CARDINAL HEALTH34B0820I34B0820I2026-10-15
10198956565388CARDINAL HEALTHPUMHPY12APUMHPY12A2026-10-15
10198956565470CARDINAL HEALTH03-2757O03-2757O2026-10-15
10198956565883CARDINAL HEALTH34-2121F34-2121F2026-10-15
10198956566613CARDINAL HEALTHSBA53BPPNDSBA53BPPND2026-10-15
10198956568969CARDINAL HEALTH34-9232B34-9232B2026-10-15
10198956569416CARDINAL HEALTHSOT48VYIWBSOT48VYIWB2026-10-15
10198956569966CARDINAL HEALTH07-8497A07-8497A2026-10-15
10198956570177CARDINAL HEALTHSOP54TJFMQSOP54TJFMQ2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956579835CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-15
10198956591707CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-15
10198956593411CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-15
10198956570993CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-13
10198956401846CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-06
10198956554146CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-06
10198956589100CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-06
10198956524316CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-10-01
10198956593268CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-30
10198956471672CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-29
10198956559547CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-29
10198956569584CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-29
10198956540408CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956569508CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956580343CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956581470CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-25
10198956569324CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956572560CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956573444CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956577091CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-21
10198956465510CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956535558CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956538344CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956538818CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956554610CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956564138CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-09-04
10198956549616CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-26
10198956547360CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956551442CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-18
10198956394773CARDINAL HEALTHCardinal Health 200, LLCOFQ2026-08-17