FDA.report

CARDINAL HEALTH

Primary DI
50195594516213
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34A8734A
Catalog number
34A8734A
Device description
SPINAL TRAY
Published
2022-02-11
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
50195594516213PackageGS170In Commercial Distribution
10195594516215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019559451621350195594516213
1019559451621510195594516215

GMDN Terms

TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia 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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