FDA.report

CARDINAL HEALTH

Primary DI
10192253036060
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
7777118477
Catalog number
7777118477
Device description
Rounded Blunt Needle Assembly, 27 G x 7/8"
Published
2024-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253036068PrimaryGS10
10192253036060Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225303606850192253036068
1019225303606010192253036060

GMDN Terms

TermDefinition
Medication transfer needle, non-filtering/non-ventedA slender, rigid, sharp or blunt metal tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It consists of a short needle sufficient to penetrate the vial stopper and extract all the medication. It is typically of 20 gauge to provide a high-flow rate with minimum coring. It does not include a filter or a back-pressure venting feature. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
5000
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
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