FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106945216
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SMA33PPSF7
Catalog number
SMA33PPSF7
Device description
PAIN PACK ODS
Published
2025-02-28
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
50197106945214PackageGS12In Commercial Distribution
10197106945216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710694521450197106945214
1019710694521610197106945216

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 Temperature040 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
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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