FDA.report

Monoject

Primary DI
50192253030745
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881560232
Catalog number
8881560232
Device description
60 mL Pharmacy Tray Luer-Lock Tip
Published
2024-02-28
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
FMFSyringe, piston

Product Code Classifications

CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253030745PackageGS112In Commercial Distribution
20192253030744PrimaryGS10
10192253030747Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225303074550192253030745
2019225303074420192253030744
1019225303074710192253030747

GMDN Terms

TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
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