FDA.report

CARDINAL HEALTH

Primary DI
50197106980246
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SAN36IREA1
Catalog number
SAN36IREA1
Device description
EAS IR PACK
Published
2025-03-14
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

Related Records

Product Codes

CodeName
OFUSpinal anesthesia kit

Product Code Classifications

CodeDeviceSpecialtyClass
OFUSpinal Anesthesia KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106980246PackageGS14In Commercial Distribution
10197106980248PrimaryGS10

GMDN Terms

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

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

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

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