FDA.report

CARDINAL HEALTH

Primary DI
50197106457366
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
34-3497B
Catalog number
34-3497B
Device description
PAIN MANAGEMENT TRAY
Published
2023-12-06
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
OFACardiovascular surgical instruments tray

Product Code Classifications

CodeDeviceSpecialtyClass
OFACardiovascular Surgical Instruments TrayCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50197106457366PackageGS113In Commercial Distribution
10197106457368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019710645736650197106457366
1019710645736810197106457368

GMDN Terms

TermDefinition
Peripheral anaesthesia single-administration set, non-medicatedA collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes 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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50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
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